HIV
and AIDS
Human Immunodeficiency Virus and
Acquired Immunodeficiency Syndrome
HIV/AIDS Historical Time Line
2000 - 2008
2000 | 2001
| 2002 | 2003
| 2004 | 2005 | 2006 | 2007 | 2008
Some of these documents are in
Portable Document Format (PDF) to retain the original format. PDF
documents may be read with a free copy of the Adobe
Acrobat Reader.
2000
- On June 19, 2000 FDA and Cal-Test Diagnostics, Chino, California signed
a consent decree to stop manufacturing and
selling its HIV in-vitro diagnostic test kits until long-standing
manufacturing problems are corrected.
- On September 15, 2000 FDA approved Kaletra (lopinavir
and ritonavir, Abbott Laboratories) for combination use with other antiretroviral
agents for the treatment of HV-1 infection in adults and pediatric patients
age six months and older.
- On October 31, 2000, FDA approved the new formulation Videx EC, enteric
coated capsule (ddI, Dideoxyinosine, Bristol Myers-Squibb)
for combination use with other antiretroviral agents, as indicated for
the treatment of HIV-1 infection in adults whose management requires once-daily
administration of didanosine or an alternative didanosine formulation.
- On November 14, 2000 FDA approved Trizivir (fixed-dose
combination of Ziagen (abacavir/ABC), Retrovir (zidovudine/AZT), and Epivir
(lamivudine/3TC) , made by Glaxo Wellcome, for the treatment of
HIV in adults and adolescents. Trizivir is not recommended for treatment
in adults or adolescents who weigh less than 40 kilograms because it is
a fixed-dose tablet.
- On December 22, 2000, FDA issued a Safety
Alert on Unapproved Goat Serum Treatment for HIV/AIDS, alerting
health care providers and patients of a potential safety concern involving
unapproved experimental product for HIV/AIDS, goat antiserum, which was
allegedly stolen from a "storage facility".
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2001
- On January 5, 2001, FDA and Bristol Myers Squibb Issued Caution
for HIV Combination Therapy with Zerit and Videx in
Pregnant Women
- On July 20, 2001, a scientific review panel confirms Condoms
Are Effective Against HIV/AIDS, but epidemiological studies
are insufficient for other STDs
- On July 26, 2001, FDA approved the Stand-Alone
(Unbundled) Package for Rebetol Capsules for use with Intron
A for the treatment of chronic hepatitis C infection,
- On September 21, 2001, FDA licensed the First
Nucleic Acid Test (NAT) systems to Screen Plasma for Human Immunodeficiency
Virus (HIV) and Hepatitis C Virus (HCV). Nucleic acid test
(NAT) systems intended for screening of plasma donors. These test systems
are expected to further ensure the safety of plasma-derived products
by permitting earlier detection of HIV and HCV infections in donors
- On September 26, 2001 FDA approved Visible Genetics, Inc., TrueGene
HIV-1 Genotyping Kit and Open Gene DNA Sequencing System to be
used to identify drug resistance in HIV patients. (Approval
Information)
- On October 26, 2001 Viread
(tenofovir disoproxil fumarate) received accelerated approval on for
treatment of HIV-1 infection in combination with other antiretroviral
medicines. Viread is the first nucleotide analog approved for HIV-1 treatment.
Nucleotides are similar to nucleoside analogs, and block HIV replication
in the same manner. Viread is manufactured by Gilead Sciences.
Approval Letter [PDF
format] | Package
Insert [PDF format]
- On November 19, 2001, FDA approved
NucliSens HIV-1 QT, made by bioMerieux, Inc., Durham, NC,
PMA number: BP010001/0. The Indication for Use is: in conjunction with
clinical presentation and other laboratory markers of disease progression
for prognostic assessment of HIV-1 infected patients, and for monitoring
the effects of anti-retroviral therapy by serial measurements of plasma
HIV-1 RNA for pediatric and adult patients with baseline viral loads
greater than 93,000 and 28,000 copies of HIV-1 viral RNA/mL respectively.
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2002
- On February 1, 2002, FDA approved a new
600 mg formulation of Sustiva (efavirenz) [PDF] to
be taken once daily, in combination with a protease inhibitor and/or
nucleoside analogue reverse transcriptase inhibitors (NRTIs), for the
treatment of HIV infection.
- On February 5, 2002, FDA approved a new
dosing regimen for Agenerase (amprenavir) and Norvir (ritonavir) used
in combination. [PDF]
- In February 2002, Changes
in the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT INFORMATION
sections of the ZERIT( (stavudine, d4T) label were made
to describe the occurrence of lactic acidosis and neuromuscular toxicity
in patients using stavudine.
- On June 26, 2002, a supplemental new drug application from GlaxoSmithKline
was approved, expanding the labeled indication to provide for the
use of Epivir (lamivudine) once daily for the treatment of HIV infection
in combination with other antiretroviral agents, and a new 300 mg tablet.
The product label was modified to reflect these changes. Epivir
Label
- FDA announced in July 2002 the analysis of findings from a 2001 study
designed to assess the extent and usefulness of private sector prescription
information patients receive when filling their prescriptions. Study
results show approximately 89 percent of patients received written information
about the drugs prescribed for them.
- In August, 2002 Product
labeling changed for AGENERASE (amprenavir) Capsules and
AGENERASE (amprenavir) Oral Solution to reflect new precautions related
to use of Agenerase with Methadone, and with oral (hormonal) contraceptives.
- On September 11, 2002, FDA approved the VERSANT HIV-1 RNA 3.0 Assay
(bDNA), manufactured by Bayer Corporation of Berkeley, CA. The
test is indicated for the direct quantitation of Human Immunodeficiency
Virus Type 1 (HIV-1) in plasma of HIV-infected individuals. This test is
intended for use in conjunction with clinical presentation and other laboratory
markers of disease status as an aid in management of individuals infected
with HIV-1. HIV-1 RNA results from the assay can be used to assess prognosis
of disease progression and to monitor the effects of antiretroviral therapy
by measuring changes in HIV-1 RNA levels during the course of therapy.
Monitoring the effects of antiretroviral therapy by serial measurements
of plasma HIV-1 RNA has been validated for patients with viral loads ³ 25,000
copies/mL. The VERSANT HIV-1 RNA 3.0 Assay (bDNA) is not intended for use
as a screening assay for HIV infection or as a diagnostic test to confirm
the diagnosis of HIV infection.
- In September 2002 The VIDEX (Didanosine, ddI) label was revised
to include new, precautionary information about co-administration of VIDEX
and ribavirin (RBV) in HIV/HCV co-infected patients. In vitro
data demonstrating that RBV increases the levels of the active Didanosine
metabolite, dideoxyadenosine 5'-triphosphate (ddATP), and clinical reports
suggesting the potential for didanosine-related toxicities led to the addition
of new precautionary language in the VIDEX label. The following has been
added to the "Precautions" section of the label: Exposure to
didanosine or its active metabolite (dideoxyadenosine 5'-triphosphate)
is increased when didanosine is co-administered with ribavirin. Increased
exposure may cause or worsen didanosine-related clinical toxicities, including
pancreatitis, symptomatic hyperlactatemia/lactic acidosis, and peripheral
neuropathy. Co-administration of ribavirin with VIDEX should be undertaken
with caution, and patients should be monitored closely for didanosine-related
toxicities. VIDEX should be suspended if signs or symptoms of pancreatitis,
symptomatic hyperlactatemia, or lactic acidosis develop.
- On September 25, 2002, FDA Announced that pharmacokinetic data demonstrated
that co-administration of VIREAD (tenofovir disoproxil fumarate)
and VIDEX (Didanosine, ddI) resulted in significant increases in didanosine
exposures; this information was included in the VIREAD label at
the time it was initially approved. Subsequent results of an interaction
study of VIREAD and VIDEX EC were submitted and reviewed. Based on this later
study, it was concluded that the magnitude of the interaction between VIREAD
and VIDEX was significant enough to warrant additional precautionary language
to be included in both products' labeling. The following precautionary language
was added: Exposure to didanosine or its active metabolite (dideoxyadenosine
5'-triphosphate) is increased when didanosine is co-administered with VIREAD.
Increased exposure may cause or worsen didanosine-related clinical toxicities,
including pancreatitis, symptomatic hyperlactatemia/lactic acidosis, and
peripheral neuropathy. Co-administration of VIREAD with VIDEX should be undertaken
with caution, and patients should be monitored closely for didanosine-related
toxicities. VIDEX should be suspended if signs or symptoms of pancreatitis,
symptomatic hyperlactatemia, or lactic acidosis develop.
- In November 2002 FDA issued new
guidance on clinical trial design in developing treatment for HIV infection [PDF].
The guidance is intended to assist sponsors in the clinical development
of drugs for the treatment of human immunodeficiency virus (HIV) infection.
Specifically, this guidance addresses the Agency's current thinking regarding
designs of clinical trials that use HIV ribonucleic acid (RNA) measurements
to support accelerated and traditional approvals of antiretroviral drug
products. It is also intended to serve as a focus for continued discussions
among the Division of Antiviral Drug Products (DAVDP), pharmaceutical
sponsors, the academic community, and the public.
- On November 7, 2002 FDA approved the first rapid HIV diagnostic
test kit for use in the United States that provides results with
99.6 percent accuracy in as little as 20 minutes. Using less than a drop
of blood collected, the OraQuick Rapid HIV-1 Antibody Test, manufactured
by OraSure Technologies, Inc., Bethlehem, Pennsylvania, can quickly and
reliably detect antibodies to HIV-1, the HIV virus that causes infection
in most cases in the U.S. Unlike other antibody tests for HIV, this test
can be stored at room temperature, requires no specialized equipment, and
may be considered for use outside of traditional laboratory or clinical
settings. Although the results of rapid screenings are reported in point-of-care
settings, as with all screening tests for HIV, if the OraQuick test gives
a reactive test result, that result must be confirmed with an additional
specific test. The OraQuick test has not been approved to screen blood
donors.
- On December 31, 2002, FDA approved a new, extended release formulation
of ZERIT® (stavudine, d4T) called ZERIT® XR, a product
of the Bristol-Myers Squibb Company. This extended-release formulation
has been demonstrated to maintain measurable plasma concentrations for
24 hours after once-daily dosing. ZERIT® XR is indicated for the treatment
of HIV in combination with other antiretrovirals. The recommended dose
of ZERIT®
XR is 100 mg once daily for individuals weighing at least 60 kg and 75 mg
once daily for individuals weighing less than 60 kg.
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2003
- In January 2003 FDA
proposed a new labeling warning statements for all over-the-counter (OTC)
vaginal contraceptive drug products containing nonoxynol 9. These
warning statements will advise consumers that vaginal contraceptives
containing nonoxynol 9 do not protect against infection from the human
immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency
syndrome (AIDS), or against getting other sexually transmitted diseases
(STDs). The warnings will also advise consumers that frequent use of
vaginal contraceptives containing nonoxynol 9 can increase vaginal irritation.
Increased vaginal irritation from use of nonoxynol 9 may increase the
possibility of transmission of the AIDS virus (HIV) and STDs from infected
partners.
- On February 3, 2003 the Department of Health and Human Services (HHS) expanded
availability of the rapid HIV test from the current 38,000 laboratories
to more than 100,000 sites, including physician offices and HIV counseling
centers. The expanded use to additional sites was granted by HHS under
a Clinical Laboratory Improvement Amendments (CLIA) waiver. Widespread
availability of the rapid HIV test is likely to increase overall HIV testing
and decrease the number of people -- an estimated 225,000 Americans --
who are unaware they are infected with the HIV virus. Early testing enables
infected individuals to obtain medical care earlier in the course of their
infection, potentially saving lives and limiting the spread of this deadly
virus. FDA approved the OraQuick test in November as a moderate complexity
test. Moderate complexity tests must be performed in a CLIA-approved laboratory
by CLIA-certified laboratory staff. Manufacturers can request a CLIA waiver
that allows the test to be used under less stringent controls. CLIA-waived
tests can be performed and interpreted in a physician's office or other
settings without having to be sent out to a CLIA-certified laboratory.
To qualify for a waiver, a test must be simple, accurate and present no
reasonable risk of harm. OraSure Technologies tested the accuracy and ease
of the test by having 102 untrained users administer the test at four sites
in the United States, including a local AIDS foundation, a program for
homeless and low income and community-based HIV organization. These users
were able to obtain results similar to those obtained in the firm's original
studies done in laboratories.
- On March 3, 2003, FDA held a meeting
of its Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee to
seek public discussion and advice on issues related to the development
of antiretroviral drugs in human immunodeficiency virus (HIV)-infected
and HIV-exposed neonates younger than 4 weeks of age. Questions
addressed included: (1) Is it feasible and ethical to conduct studies of
antiretroviral drugs in HIV-infected or exposed neonates in the United
States? (2) Should we continue to request pharmacokinetic and safety studies
in HIV infected neonates for every drug under development or should we
develop criteria for deciding which drugs should be studied. (3) If studies
are conducted in resource poor countries, where perinatal transmission
rates are still unacceptably high, can the results be extrapolated to pertain
to the U.S. population?
Briefing Information | Slides | Minutes | Complete
Transcript
- On March 15, 2003 FDA
approved FUZEON (enfuvirtide, also known as T-20), for use
in combination with other anti-HIV medications to treat advanced HIV-1
infection in adults and children ages 6 years and older. This marked
the first approval, worldwide, of a new class of drugs known as "fusion
inhibitors,"
which interfere with the entry of HIV-1 into cells by inhibiting the merging
of the virus with the cellular membrane. This inhibition blocks HIV before
it enters the human immune cell. Roche Pharmaceuticals of Nutley, N.J., has
licensed the product from Trimeris Inc. of Durham, NC, and will distribute
FUZEON. Additional Information
on FUZEON: Choose "F" from the Index, and scroll down to "Fuzeon"
at the end of the list.
- On April 1, 2003 a special nutrition
management and HIV infection supplement to Clinical Infectious
Diseases, a journal of The Infectious Diseases Society of America, was
published (Clinical Infectious Diseases, Volume 36, Supplement 2), stressing
the importance of nutrition as part of the medical treatment of HIV.
It contains a special report on current issues related to The
supplement is a collaborative work of more than 50 authorities representing
a wide range of expertise in conjunction with 5 federal agencies: the
Health Resources and Services Administration, the Food and Drug Administration,
the Centers for Disease Control and Prevention, the National Institutes
of Health, and the Department of Veterans Affairs.
- On April 30, 2003, the Food and Drug Administration approved a new
dosing formulation of Viracept (nelfinavir mesylate) a protease
inhibitor indicated for the treatment of HIV-1 infection in combination
with other antiretroviral agents. Viracept has been available in 50 mg
oral powder and 250 mg tablets. The new formulation of 625 mg reduces the
pill burden from five-250 mg tablets twice a day to two-625 mg tablets
twice a day, potentially facilitating adherence to treatment regimens.
- On May 13, 2003, FDA held a meeting
of its Antiviral Drugs Advisory Committee to discuss the new
drug applications (NDA) 21-567 and 21-568, Reyataz™ (atazanavir sulfate) capsules
and powder for oral use, Bristol-Myers Squibb Company, proposed for the
treatment of HIV infection in combination with other antiretroviral agents.
Briefing Information | Transcript | Slides
- On June 20, 2003, FDA
approved Reyataz (atazanavir sulfate) [PDF],
a protease inhibitor, manufactured by Bristol-Myers Squibb Company of
Princeton, NJ, to be used in combination with other anti-retroviral agents
for the treatment of patients with HIV infection. Approval of this drug
permits patients access to a once-a-day protease inhibitor. Reyataz appears
to have minimal impact on lipid parameters such as triglycerides and
cholesterol. Product
Label
- On July 2, 2003, FDA
approved Emtriva (FTC, emtricitabine) [PDF],
a new nucleoside reverse transcriptase inhibitor (NRTI) manufactured
by Gilead Sciences, Foster City, CA, USA, for use in combination with
other anti-retroviral agents for the treatment of patients with HIV infection. Product
Label
- In July 2003 an important drug warning was issued regarding Early
Virologic Non-Response in Patients with HIV Infection Treated With Lamivudine,
Abacavir and Tenofovir.
- On August 8, 2003, an important drug warning was issued regarding Important
New Pharmacokinetic Data for REYATAZ™ (atazanavir sulfate) in combination
with Viread®
(tenofovir disoproxil fumarate)
- On August 15, 2003, Viread labeling was updated to include
results from Gilead Sciences study 903 (antiretroviral naïve subjects).
The revised label also includes new dose recommendations for patients with
renal impairment, a new warning about HIV/HBV coinfection, dose recommendation
for ddI when used with tenofovir, and updated information regarding bone
effects. In addition, the original label stated that Viread should be taken
with a meal. New information indicates that Viread may be taken without regard
to food. This information can be found in the Dosage and Administration section
of the new label.
- On August 20, 2003, FDA held a meeting
of its Antiviral Drugs Advisory Committee to discuss clinical
trial design issues in the development of topical microbicides for the
reduction of HIV transmission.
Agenda | Briefing
Information | Slides
Back to Top
2004
- On January 12, 2004 FDA approved a labeling supplement for Crixivan
(Indinavir Sulfate) Capsules summarizing tubulointerstitial nephritis
with medullary calcification and cortical atrophy observed in patients
with asymptomatic severe leukocyturia (>100 cells/high power field)
and reports of Immune reconstitution syndrome in patients treated with
combination antiretroviral therapy (CART), including CRIXIVAN. During the
initial phase of treatment, patients responding to antiretroviral therapy
whose immune system responds to CART may develop an inflammatory response
to indolent or residual opportunistic infections (such as MAI, CMV, PCP,
or TB), which may necessitate further evaluation and treatment." Additionally,
information was added about Reyataz (atazanavir):
"Both CRIXIVAN and atazanavir are associated with indirect (unconjugated)
hyperbilirubinemia. Combinations of these drugs have not been studied and
coadministration of CRIXIVAN and atazanavir is not recommended." Changes
were also made to the Patient Package Insert (PPI) indicating that "In
some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation
from opportunistic infections may occur when combination antiretroviral treatment
is started.
- In March 2004, new drug interaction information led to changes
in the REYATAZ (atazanavir sulfate) label based on drug-drug interactions.
Tenofovir decreases the AUC (area under the curve) and Cmin (minimum concentration)
of REYATAZ. When coadministered with tenofovir, it is recommended that
REYATAZ 300 mg is given with ritonavir 100 mg and tenofovir 300 mg (all
as a single daily dose with food). REYATAZ without ritonavir should not
be coadministered with tenofovir.
- In March, 2004, FDA has approved new dosing recommendations for
VIRACEPT (nelfinavir) in patients 2 years of age or older, based
on clinical and pharmacokinetic data from 5 pediatric studies.
- On March 19, 2004, FDA approved the OraSure rapid test for detection
of HIV-2 when used with a whole blood sample. The rapid test kit
is identical to the earlier approved version, however, subsequent data
submitted to the agency has demonstrated its ability to detect HIV-2.
- On March 26, 2004, FDA approved the use of oral fluid samples with
a rapid HIV diagnostic test kit that correctly identified 99.3
of specimens from infected people (sensitivity) and 99.8% of specimens
from uninfected people (specificity) in limited studies provided by the
manufacturer in support of this approval. The test provides the result
in approximately 20 minutes.
- On March 26, 2004, the OraQuick Rapid HIV-1 Antibody Test was approved
for testing plasma for HIV-1 and HIV-2 (a variant of HIV that
is prevalent in parts of Africa but rarely found in the United States).
- In May, 2004, FDA approved changes in the label for Voriconazole
(VFEND) triazole antifungal agent to include drug interaction
information when coadministered with efavirenz or ritonavir.
- In May, 2004, revisions were made to the Crixivan product label
to reflect data about drug-drug interactions, including those
related to VIAGRA (sildenafil), CIALIS (tadalafil), or LEVITRA (vardenafil),
and REYATAZ (atazanavir).
- On May 17, 2004, FDA issued a guidance
document that describes a process to expedite approval of low cost, safe
and effective co-packaged and fixed dose combination (FDC) HIV therapies so
that high quality drugs can be made available in Africa and developing
countries around the world under the President's Emergency Plan for AIDS
Relief.
- On May 20, 2004, FDA published a new Final Rule on Donor Eligibility
for Human Tissues and Cells (Eligibility Determination for Donors
of human Cells, Tissues, and Cellular and Tissue-Based Products), and draft
guidance (Guidance for Industry Eligibility Determination for Donors of
Human Cells, Tissues, and Cellular and Tissue-Based Products) related to
donor screening and eligibility. These documents include HIV, among a variety
of conditions for which cell and tissue donor screening would be required. Federal
Register Notice (PDF 363 MB); Draft
Guidance Document (PDF 143 MB); Questions
and Answers
- In May, 2004, FDA and Bristol-Myers Squibb notified healthcare professionals
of revisions to the CLINICAL PHARMACOLOGY and PRECAUTIONS sections
of the product labeling for DESYREL (trazodone hydrochloride) Tablets,
indicated for the treatment of depression, citing a potential for drug interactions
when trazodone is given with the CYP3A4 inhibitors ketoconazole, ritonavir,
and indinavir. Dear Health
Care Provider Letter
- On June 25, 2004, FDA granted a CLIA (Clinical Laboratory Improvements
Amendments of 1988] waiver to the OraQuick ADVANCE Rapid HIV-1/2 Antibody
Test for use with oral fluid, a fast and non-invasive test approved
on March 26, 2004, to detect antibodies to HIV-1 in oral fluid. The oral
fluid indication was extended by FDA to include detection of antibodies
to HIV-2 in oral fluid on June 22, 2004. The CLIA waiver allows the rapid
oral fluid test to be used in more health care settings, such as doctors'
offices, clinics, and some mobile labs that can offer testing in high-risk
areas. Through these venues, testing are accessible to many more people,
particularly to those individuals who are reluctant to be tested due to
the need to draw blood.
- On July 1, 2004, the VIREAD (tenofovir disoproxil fumerate) label
was updated to recommend against use in patients with chronic hepatitis
B infection, because of severe, acute exacerbations of Hepatitis
B may occur in patients who are coinfected with hepatitis B and HIV and
have discontinued Viread.
- On July 6, 2004, FDA approved a new dosing regimen for REYATAZ of
300 mg (two 150 mg capsules) once daily plus ritonavir 100 mg once daily
taken taken with food in antiretroviral-experienced patients. For antiretroviral-naïve
patients the recommended dose remains as REYATAZ 400 mg (two 200 mg capsules)
once daily with food.
- On July 27, 2004, FDA launched a new web page to consolidate records
of advisory committee meetings related to HIV/AIDS and associated conditions,
making them easier to access. The new page, which lists HIV/AIDS-related
advisory committee meetings held since 1996, indexed by topic and by year.
It is the first consolidation of advisory committee records by topic, and
includes records of meeting held by advisory committees related to drugs,
biologics, and medical devices, with links to a variety of documents, such
as meeting announcements, committee rosters, briefing materials - which
often contain background materials and slides - and meeting transcripts.
Topics include consideration of new drug applications, regulatory policy
issues, and trial design topics. FDA
Advisory Committees Page.
- On August 2, 2004, FDA approved two fixed-dose combination (FDC)
antiretroviral drug products for use with other antiretroviral
agents for the treatment of HIV-1 infection. The FDCs are GlaxoSmithKline's
EPZICOM (abacavir/lamivudine) and Gilead Sciences, Inc.'s TRUVADA (tenofovir
disoproxil/emtricitabine). These FDC approvals are important because they
provide simplified dosing regimens - one pill, once daily, for the component
of multi-drug therapy represented by these FDCs.
- On August 3, 2004, FDA approved Sculptra to correct facial fat
loss in people with human immunodeficiency virus (HIV). Sculptra,
a medical device, is a product of Dermik Laboratories, of Berwyn, PA. It
is an injectable form of poly-L-lactic acid, a biodegradable, biocompatible
synthetic polymer from the alpha-hydroxy-acid family that has been widely
used for many years in dissolvable stitches, bone screws and facial implants.
It is the first such treatment approved for the condition known as lipoatrophy,
or facial wasting. FDA expedited review of the product because of its importance
in treating people living with AIDS.
- In August 2004, Sustiva labeling was revised to include
safety and efficacy data representing 168 weeks of treatment from Study 006
( efavirenz + lamivudine + zidovudine vs indinavir + lamivudine + zidovudine
vs efavirenz + indinavir) and other available data.
- On September 23, 2004, FDA held a meeting of its Vaccines and Related Biological
Products Advisory Committee (VRBPAC) to update the Committee on the phase
3 Thai trial of ALVAC vCP 1521 [Aventis Pasteur, Inc.] with AIDSVAX B/E [VaxGen,
Inc.] (HIV-1 Recombinant Canarypox-Vectored Vaccine with Recombinant
gp 120 B/E) for the prevention of HIV-1 infection.
- On October 7, 2004, FDA held a public workshop entitled "From
Concept to Consumer: Center for Biologics Evaluation and Research (CBER)
Working with Stakeholders on Scientific Opportunities for Facilitating
Development of Vaccines, Blood and Blood Products, and Cellular, Tissue,
and Gene Therapies" to provide stakeholders a forum for the
development of innovative scientific knowledge and tools to facilitate
the development and availability of new biological products including vaccines,
blood and blood products, and cellular, tissue, and gene therapies.
- In October 2004, Kaletra (lopinavir and ritonavir) Soft Gel Capsules
and Oral Solution labeling was revised to include long-term (week
144-204) efficacy and safety results from two phase II trials. These were
the Week 204 efficacy results from study M97-720 in antiretroviral-naïve
subjects and the Week 144 results from study M97-765 in antiretroviral-experienced
subjects were included in the label. In addition, results of a multiple
dose study in HIV and HCV co-infected subjects with mild to moderate hepatic
impairment and Week 104 mice and rat data were submitted to update the
respective sections of the package insert.
- On October 15, 2004, FDA granted" traditional approval"
for Fuzeon (enfuvirtide, also known as T-20) injection, in combination
with other antiretroviral agents, for the treatment of HIV-1 infection in
treatment experienced patients with ongoing viremia. FDA originally approved
Fuzeon on March 13, 2003 under the regulations at 21 CFR 314, Subpart H,
for accelerated approval of new drugs for serious or life-threatening illnesses.
- On November 12, 2004 Bristol-Myers Squibb (BMS) issued a "Dear
Healthcare Provider" letter regarding is important new
clinical data regarding coadministration of Viread (tenofovir disoproxil
fumarate [TDF]), Videx EC (didanosine delayed-release capsules enteric-coated
beadlets [ddI EC]), and either Sustiva (efavirenz [EFV]) or Viramune (nevirapine
[NVP]).
- In November, 2004, FDA issued final guidance on the "Use
of Nucleic Acid Tests on Pooled and Individual Samples from Donors of
Whole Blood and Blood Components (including Source Plasma and Source
Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission
of HIV-1 and HCV."
- On November 26, 2004 FDA issued draft guidance for industry entitled
"Role of HIV Drug Resistance Testing
in antiretroviral Drug Development," addressing the role
of HIV resistance testing during antiretroviral drug development and postmarketing.
The draft guidance discusses the nonclinical studies (mechanism of action;
antiviral activity in vitro; cytotoxicity/therapeutic index; and the effects
of serum protein binding on antiviral activity) recommended be completed
prior to the initiation of phase 1 clinical studies in HIV-infected patients,
as well as the use of resistance testing in the clinical phases of drug development
and recommends the type of information that should be collected, and the
types of analyses that should be conducted to characterize an antiretroviral's
resistance profile. It also reviews the role of resistance testing in initial
activity and dose-finding, for study enrollment criteria, for background
regimen selection, and to establish an indication.
- On December 3, 2004, FDA approved a generic formulation of Didanosine
(ddI) Delayed Release capsules, 200 mg, 250 mg, and 400 mg for
use in combination with other antiretroviral agents in the treatment of
HIV-1 infection in adults. The product, manufactured by Barr Laboratories,
Inc. of Pomona, NY, is the first approval in the United States
of a generic antiretroviral therapeutic formulation to treat HIV/AIDS.
- On December 17, 2004, FDA approved a new 500 mg tablet formulation
of the HIV protease inhibitor, INVIRASE (saquinavir mesylate).
The dosage and administration for INVIRASE in adults (over the age of 16
years) is 1000 mg twice a day (taken as either two 500 mg tablets or five
200 mg capsules) in combination with ritonavir 100 mg twice a day, after
a meal. The new tablet formulation reduces the pill burden compared to
the capsule formulation.
- On December 30, 2004, FDA
approved the Multispot HIV-1/HIV-2 Rapid Test. This
device, manufactured by Bio-Rad Laboratories, Redmond, WA, is indicated
for the detection and differentiation of circulating antibodies associated
with HIV-1 and HIV-2 in human plasma and serum, as an aid in the diagnosis
of infection with HIV-1 and/or HIV-2.
Back to Top
2005
- On 1/26/2005, FDA announced the first tentative approval under
a new FDA review process designed to expedite the availability of generic
products under the President's Emergency Plan for AIDS Relief (PEPFAR).
The product was a new copackaged antiretroviral drug regimen, consisting
of both lamivudine/zidovudine fixed dose tablets (a version of Combivir
tablets manufactured by GlaxoSmithKline) and nevirapine tablets(a version
of Viramune tablets manufactured by Boehringer-Ingelheim), one of each
tablet to be taken twice daily, after the initial two week initiation phase
of this nevirapine regimen. The product was manufactured by Aspen Pharmacare
of South Africa. Tentative Approval means that FDA concluded the drug product
met all of the required quality, safety and efficacy standards, even though
it may not yet be marketed in the U.S. due to existing patents and/or exclusivity.
It did, however, make the product eligible for use under PEPFAR, and the
first tentative approval of an HIV drug regimen manufactured by a non-U.S.-based
generic pharmaceutical company.
- On 2/8/2005, FDA Roche Laboratories Inc. issued a "Dear Health Care
Provider" letter, created in collaboration with FDA, to communicate
an important drug interaction warning for saquinavir/ritonavir, and
rifampin, an antibacterial agent: drug-induced hepatitis with marked
transaminase elevations has been observed in healthy volunteers receiving
rifampin 600 mg once daily in combination with ritonavir 100 mg/saquinavir
1000 mg twice daily (ritonavir boosted saquinavir). As a result of high incidence
of hepatotoxicity in a Phase I, randomized, open-label, multiple-dose clinical
pharmacology study in healthy volunteers, the letter advised prescribers
that: Rifampin SHOULD NOT be administered to patients also receiving saquinavir/ritonavir
(ritonavir boosted saquinavir) as part of combination antiretroviral therapy
(ART) for HIV infection.
- FDA approved, on February 25, 2005, efficacy supplements for Pegasys
(peginterferon alfa-2a) and Copegus (ribavirin), making them the first
approved therapies for treatment of Hepatitis C in patients coinfected
with HIV. The approvals expand the therapeutic indications to
include Peg-interferon alone, or in combination with ribavirin, for the
treatment of adult chronic hepatitis C in patients coinfected with HIV,
who have clinically stable HIV disease (patients either on stable HIV antiretroviral
therapy, or those who have not met the criteria to begin therapy).
- In March of 2005, the Norvir (ritonavir) and Kaletra (lopinavir/ritonavir)
package inserts (product labeling) were updated to include information
regarding interactions with fluticasone (a synthetic corticosteroid, the
active component of Flonase nasal Spray) and trazodone (Desyrel, a non-tricyclic
antidepressant). In addition, alfuzosin (an alpha-blocker used
to increase the flow of urine in people with benign prostatic hypertrophy
(BPH)) was added to the Contraindications section of the Norvir package
insert.
- On March 31, 2005, Bristol-Myers Squibb Company has issued a Dear Health
Care Provider Letter, developed in collaboration with FDA, highlighting the
important change in Sustiva (efavirenz) from Pregnancy Category C
to D (Risk of Fetal Harm Cannot Be Ruled Out) to Category D (Positive Evidence
of Fetal Risk). The change came as a result of four retrospective
reports of neural tube defects in infants born to women with first trimester
exposure to Sustiva including three cases of meningomyelocele and one Dandy
Walker Syndrome. Because of the potential for fetal harm when administered
during the first trimester to a pregnant woman, pregnancy should be avoided
in women receiving SUSTIVA.
- On April 29, 2005, FDA approved the use of KALETRA 800/200mg once-daily
administration for the treatment of HIV-infection in therapy-naïve
adult patients, based on review and analysis of two clinical trials
comparing safety and efficacy of lopinavir (LPV)/ritonavir (RTV) 800/200
mg once daily (qd) and LPV/RTV 400/100 mg twice daily (bid), for a duration
of at least 48 weeks in antiretroviral-naïve HIV-1 infected subjects.
- On May 12, 2005, the FDA approved a new 30-count bottle for Norvir
(ritonavir) Soft Gelatin Capsules, 100 mg. Previously only 120-count
bottles were available. The new 30-count bottle is more convenient for
pharmacy dispensing, and for patients who use Norvir 100 mg once or twice
daily in combination with other protease inhibitors.
- On May 12, 2005, FDA approved new labeling for Viread (tenofovir
disoproxil fumarate). The label was updated to include results
from a 144 week efficacy and safety data in treatment-naïve patients
that fulfilled part of the requirement for traditional approval by confirming
long-term efficacy in treatment-naïve patients, and by providing long-term
safety information with respect to bone effects.
- On May 19, 2005, FDA held a meeting
of its Antiviral Drugs Advisory Committee to consider data relative to Aptivus
(Tipranavir), 250 milligrams (mg) capsules, new drug application
(NDA) 021-814 (Boehringer Ingelheim Pharmaceuticals, Inc.), indicated for
the treatment of patients with HIV.
- On May 25, 2005 the Food and Drug Administration issued draft
guidance to assist product sponsors in the development of antiviral
drug products and to serve as a starting point for understanding
the nonclinical and clinical virology data important to support clinical
trials of antiviral agents. This guidance focuses on nonclinical and
clinical virology reports, which are essential components in the review
of investigational antiviral drugs. Because of the experience, history,
and lessons learned with HIV-1 studies, the guidance focuses on studies
commonly used to evaluate HIV-1 drugs and uses them as a model for future
studies of drugs to treat other viruses.
- On May 27, 2005FDA granted "tentative approval" for a
generic formulation of lamivudine tablets, 150 mg, manufactured
by Ranbaxy Laboratories Limited (India), for use in combination with other
antiretroviral agents in the treatment of HIV-1 infection in adults. A
Tentative Approval means that FDA had reviewed an Abbreviated New Drug
Application (ANDA), and concluded that a drug product had met all of the
required quality, safety and efficacy standards, even though it may not
yet be marketed in the U.S. due to existing patents and/or exclusivity.
It did, however, make the product eligible for use under the President's
Emergency Plan for AIDS Relief (PEPFAR) program outside the United States.
The lamivudine tablets are a generic version of Epivir (lamivudine) Tablets,
150 mg, manufactured by Glaxo Smith Kline. A second generic formulation
was granted a tentative approval on June 15, 2005 for generic
lamivudine tablets, 150 mg and 300 mg, manufactured by Aurobindo Pharma
Ltd., Hyderabad, India. Lamivudine tablets are indicated for use in combination
with other antiretroviral agents for the treatment of HIV-l infection.
- On May 31, 2005 FDA approved a generic formulation of foscarnet
sodium injection, 24 mg/mL, 250 mL and 500 mL single-dose containers,
manufactured by Pharmaforce, Inc., of Columbus, Ohio. The product is indicated
for the treatment of CMV retinitis in patients with acquired immunodeficiency
syndrome (AIDS), making a generic alternative formulation of Foscavir (foscarnet
sodium Injection) 24 mg/mL, 250 mL and 500 mL single-dose containers, manufactured
by Astra Zeneca, originally approved in 1991,available in the United States.
- On June 20, 2005, FDA announced the tentative approval of two applications
for nevirapine tablets manufactured by Ranbaxy Laboratories Limited,
Guragon, India and Aurobindo Pharma Limited, Hyderabad, India. Although
existing patents and/or exclusivity prevent the marketing of Aurobindo's
and Ranbaxy's products in the United States, the products, tentative approval
allows consideration of these products for purchase under the President's
Emergency Plan for AIDS Relief (PEPFAR).
- On June 22, 2005, FDA granted accelerated approval of APTIVUS (tipranavir),
a protease inhibitor. APTIVUS, co-administered with 200 mg of ritonavir,
is indicated for use as part of combination antiretroviral treatment of HIV-1
infected adult patients with evidence of viral replication, who are highly
treatment-experienced or have HIV-1 strains resistant to multiple protease
inhibitors. FDA reviewed and approved APTIVUS in a six month time frame.
- On June 24, 2005 FDA granted tentative approval for generic efavirenz
tablets manufactured by Aurobindo Pharma LTD. of Hyderabad, India,
the first tentatively approved generic version of Sustiva tablets (manufactured
by Bristol-Myers Squibb). Efavirenz is a member of the non-nucleoside reverse
transcriptase inhibitors (NNRTIs) Tentative approval means that although
existing patents and/or exclusivity prevent marketing of a particular product
in the United States, it meets all of FDA's quality, safety and efficacy
standards required for marketing in the United States which allows this
product to be considered for purchase under the President's Emergency Plan
for AIDS Relief (PEPFAR).
- On July 1, 2005 FDA announced the tentative approval for generic
stavudine capsules manufactured by Aurobindo Pharma LTD., Hyderabad,
India, a generic version of the approved drug, Zerit, a Nucleoside Reverse
Transcripts Inhibitors (NRTIs)manufactured by Bristol-Myers Squibb. Tentative
approval means that although existing patents and/or exclusivity prevent
marketing the particular product in the U.S. at this time, the product
meets all FDA's quality, safety and efficacy standards. The tentative approval
allows this product to be considered for purchase under the President's
Emergency Plan for AIDS Relief (PEPFAR).
- On July 7, 2005, granted tentative approval for a generic combination
drug product consisting of lamivudine and zidovudine, manufactured
by Aurobindo Pharma LTD. Hyderabad, India.FDA tentative approval means
that the product meets all of FDA's quality, safety and efficacy standards,
but existing patents and/or exclusivity prevent marketing of the product
in the U.S. Tentative approval by FDA, however, makes this Aurobindo generic
product available for consideration for purchase and use outside the United
States under the President's Emergency Plan for AIDS Relief (PEPFAR).The
Aurobindo lamivudine/zidovudine combination product is a generic version
of the U.S. approved Combivir lamivudine/zidovudine combination manufactured
by GlaxoSmithKline.
- On July 13, 2005 FDA announced the tentative approval of generic
zidovudine tablets manufactured by Ranbaxy Laboratories Limited
of Guragon, India. The product contains 300 mg of zidovudine in each tablet.
It is a generic version of the already-approved Retrovir brand of the product
manufactured by GlaxoSmithKline. Tentative approval means that although
existing patents and/or exclusivity prevent marketing of this product in
the United States, it meets the quality, safety and efficacy standards
for U.S. marketing. Tentative approval by FDA makes the generic product
eligible for purchase and use outside the United States under the President's
Emergency Plan for AIDS Relief.
- On September 7, 2005 FDA granted tentative approval for a generic
zidovudine oral solution manufactured by Aurobindo Pharma LTD.
Hyderabad, India. This product is the first tentatively approved
generic version of Retrovir brand of the zidovudine oral solution (manufactured
by GlaxoSmithKline). This oral dosage form of the drug is the first pediatric-friendly
oral solution available for consideration for purchase under the President's
Emergency Plan for AIDS Relief (PEPFAR). This product contains 50 mg/5mL
of zidovudine in an oral solution. Tentative approval means that although
existing patents and/or exclusivity prevent marketing of this product in
the United States, it meets all of FDA's quality, safety and efficacy standards
for U.S. marketing.
- On September 19, 2005, FDA approved three generic formulations
of Zidovudine for the U.S. market. Previously, the products had
been only tentatively approved and were not available in the United States
because patent or market exclusivity blocked their approval for domestic
marketing. With the expiration of those patents, the following products
have received full marketing authorization for the United States:
(1) zidovudine tablets, 300 mg , manufactured by Ranbaxy Laboratories Limited
of Guragon, India;
(2) zidovudine tablets, 300 mg and oral solution, 50 mg/5mL, manufactured
by Aurobindo Pharma LTD. Hyderabad, India; and
(3) zidovudine tablets, 300 mg, manufactured by Roxane Laboratories of Columbus,
Ohio, U.S.A. These are generic versions of Retrovir brand manufactured by
GlaxoSmithKline.
- On September 28, 2005 the Food and Drug Administration approved
EMTRIVA (emtricitabine) Oral Solution 10 mg/mL. The approval of
this Oral Solution formulation allows for dosing recommendations
in pediatric patients. EMTRIVA is now indicated in combination
with other antiretroviral agents, for the treatment of HIV-1 infection
in patients over three months of age.
- On October 6, 2005, FDA approved dosing recommendations for NORVIR
(ritonavir) in pediatric patients one month to two years of age.
- On October 28, 2005 the Food and Drug Administration approved a
new formulation of Kaletra. Kaletra (lopinavir/ritonavir) became
available as a film coated tablet (200mg/50mg) that provides advantages
over the currently marketed capsule formulation for HIV-1 infected patients.
Specifically, the tablet formulation does not require refrigeration, can
be administered without regard to meals, does not require dose adjustments
for concomitant use with certain NNRTIs and PIs in treatment-naïve
patients and has a decreased pill burden compared to the capsule formulation
(2 tablets twice daily or 4 tablets once daily in treatment-naïve
patients only vs 3 capsules twice daily or 6 capsules once daily in treatment-naïve
patients only).
- On November 3, 2005 the Food and Drug Administration held a meeting of
its Blood Products Advisory Committee (BPAC) to discuss important
issues related to home-use rapid HIV test kits. The Committee heard
a proposal by OraSure Technologies, Inc. for over-the-counter (OTC) availability
of the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test for use with oral fluid
specimens, and discussed issues related to proposed studies to validate adequate
performance in the hands of intended users, and the ability of informational
materials to provide counseling and other information regarding accuracy
of testing, correct test interpretation, management of psychological and
social issues, and medical referral. The committee also considered the role
of rapid HIV tests in CDC's Advancing HIV Prevention initiative and CDC's
current HIV test counseling recommendations, the role of quality systems
in diagnostic testing, psychological and social issues associated with HIV
testing, and prior experience with approved home-use test kits.
- On November 4, 2005 FDA announced the tentative approval of Lamivudine
Oral Solution, 10 mg/mL manufactured by Aurobindo Pharma LTD.
of Hyderabad , India. Lamivudine Oral Solution was the first generic version
of the already approved Epivir Oral Solution, 10 mg/mL, manufactured by
GlaxoSmithKline. This child-friendly-product is indicated for use in pediatric
patients with HIV from three months to 16 years. FDA's tentative approval
of this product means that although existing patents and/or exclusivity
prevent marketing of this product in the United States, the product meet
all of FDA's safety, efficacy, and manufacturing quality standards required
for marketing in the U.S. and becomes eligible for consideration for purchase
under the President's Emergency Plan for AIDS Relief (PEPFAR).
- On November 14, 2005 FDA published information about proposed changes
in the way condoms are to be regulated, and draft guidelines for condom
labeling. The agency solicited input to help finalize the guidance.
FDA proposed to amend the classification regulations to designate a special
control for natural rubber latex (latex) condoms, with and without spermicidal
lubricant, and proposed new guidelines to specify the kind of labeling
that will be considered sufficient and appropriate for the products.
Three separate documents were published on November 14, 2005 to support
these proposed changes:
- Proposed Rule -
Obstetrical and Gynecological Devices; Designation of Special Control
for Condom and Condom With Spermicidal Lubricant
- Class II Special Controls Guidance
Document: Labeling for Male Condoms Made of Natural Rubber Latex
- Draft Guidance -
Class II Special Controls Guidance Document: Labeling for Male Condoms
Made of Natural Rubber Latex.
- On December 21, FDA granted tentative approval for generic stavudine
for Oral Solution, 1 mg/mL manufactured by Aurobindo Pharma LTD.,
of Hyderabad, India. This was the first generic version of the approved
product, Zerit for oral solution, manufactured by Bristol-Myers Squibb.
This child-friendly product is indicated for use in pediatric patients
with HIV from birth through adolescence. FDA's tentative approval of this
product means that although existing patents and/or exclusivity prevent
marketing of this product in the United States, the product meet all of
FDA's safety, efficacy, and manufacturing quality standards required for
marketing in the U.S. and becomes eligible for consideration for purchase
under the President's Emergency Plan for AIDS Relief (PEPFAR).
- FDA, on December 27, 2005, granted tentative approval, through
an expedited procedure, to generic Nevirapine Oral Suspension,
50 mg/5 mL, manufactured by Aurobindo Pharma LTD., of Hyderabad, India.
This was a generic version of the approved product, Viramune Oral Suspension,
50 mg/5 mL, manufactured by Boehringer Ingelheim Pharmaceuticals indicated
for use in pediatric patients with HIV. FDA's tentative approval of this
product means that although existing patents and/or exclusivity prevent
marketing of this product in the United States, the product meet all of
FDA's safety, efficacy, and manufacturing quality standards required for
marketing in the U.S. and becomes eligible for consideration for purchase
under the President's Emergency Plan for AIDS Relief (PEPFAR).
Back to Top
2006
- FDA approved updates to the REYATAZ (atazanavir sulfate) package
insert on January 25, 2006, to reflect new in vitro inhibition
data and clinical drug-drug interaction information regarding coadministration
of atazanavir and/or atazanavir/ritonavir with proton pump inhibitors,
H2 receptor antagonists, methadone, rifampin, enteric-coated didanosine
and tenofovir. The complete revised label is available at http://www.fda.gov/cder/foi/label/2006/021567s007lbl.pdf
- FDA held a public workshop on March 8, 2006, entitled "Behavior-Based
Blood Donor Deferrals in the Era of Nucleic Acid Testing [NAT)."
The workshop provided an opportunity for public discussion on the scientific
basis for behavior-based donor deferral criteria, and the value of their
continued use now that nucleic acid based tests (NAT) are available for certain
transfusion-transmissible agents. Meeting
transcript.
- On March 10, 2006, FDA held a meeting of its Blood Products Advisory Committee
to discuss the design of proposed studies to support the approval of over-the-counter
(OTC) home-use human immunodeficiency virus (HIV) test kits. The agency sought
the advice of the Committee on proposed studies that would be needed to validate
a home-use HIV test kit with regard to test accuracy, test interpretation,
and medical follow-up based on the provision of informational material in
place of a trained test operator and counselor. Meeting
transcript.
- On March 6, 2006 FDA granted tentative approval for a copackaged
antiretroviral drug regimen, consisting of lamivudine/zidovudine fixed
dose combination tablets and efavirenz tablets, for the treatment
of HIV-1 infection in adults. It was manufactured by Aurobindo Pharma Ltd.,
Hyderabad, India. There was no predicate version of this co-packaged product
approved in the United States. A Tentative Approval means that FDA has
concluded that a drug product has met all required quality, safety and
efficacy standards, though it may not yet be marketed in the U.S. due to
existing patents and/or exclusivity rights. Tentative approval, however,
does make the product eligible for consideration for purchase under the
President's Emergency Plan for AIDS Relief (PEPFAR) program.
- On March 8, 2006, FDA granted traditional approval to two tenofovir
DF containing products manufactured by Gilead Sciences, VIREAD
(tenofovir disoproxil fumarate) and TRUVADA (fixed dose combination of
tenofovir DF and emtricitabine). Both products are indicated for the treatment
of HIV in combination with other antiretroviral drugs. VIREAD and TRUVADA
had received accelerated approval on Oct. 26, 2001 and August 2, 2004,
respectively. Traditional approval is supported by previously submitted
studies and the recently submitted Study 934, which compared the antiviral
activity of tenofovir DF, emtricitabine, and efavirenz to zidovudine, lamivudine
and efavirenz in treatment naïve HIV-infected individuals receiving
these regimens through 48 weeks.
- The FDA, on March 27, 2006, granted approval for generic zidovudine
100 mg capsules manufactured by Aurobindo Pharma Limited Inc.,
of Hyderabad, India. This was a generic version of the already-approved
Retrovir brand of the product manufactured by GlaxoSmithKline.The tablet
and oral solution dosage forms of zidovudine were previously approved for
sale in the United States when the patent on those dosage forms expired
in September 2005. The approval for the capsule formulation followed
expiration of GlaxoSmithKline's patent on its capsule form of the product
marketed under the trade name Retrovir and means that the capsules are
available in the United States, and eligible for consideration for purchase
under the President's Emergency Plan for AIDS Relief (PEPFAR) program.
- On May 4, 2006 FDA is issued guidance regarding data to support the: 1)
Initiation of pediatric studies of a preventive HIV vaccine under a United
States (U.S.) investigational new drug application (IND); and 2) licensure
of a preventive HIV vaccine for pediatric use. The guidance also provides
recommendations to investigators and institutional review boards (IRBs) who
are involved with these pediatric studies. The guidance is
available on the FDA web site.
- On May 18, 2006 FDA granted tentative approval for a generic version
of abacavir sulfate tablets, 300 mg, manufactured by Aurobindo
Pharma LTD. of Hyderabad, India. Abacavir sulfate tablets was the first
generic version of FDA approved Ziagen Tablets manufactured by GlaxoSmithKline.
The agency's tentative approval meant that Aurobindo's product met all
of FDA's manufacturing quality and clinical safety and efficacy standards,
but existing patents and/or exclusivity prevent its marketing in the United
States at this time. Tentative approval made this product available for
consideration for purchase under the President's Emergency Plan for AIDS
Relief (PEPFAR).
- On May 31, 2006, FDA cosponsored an open public meeting to discuss
issues regarding the development of CCR5 co-receptor antagonists for
the treatment of HIV infection with the Forum for Collaborative HIV Research. To
help improve the development of this complex class of HIV therapy, issues
for discussion included mechanisms for long-term follow-up to monitor safety
of patients enrolled in CCR5 antagonist clinical trials, potential consequences
of viral tropism changes, and characterization of resistance to these investigational
agents.
- On June 8, 2006 FDA published a final Guidance for Industry
on Antiviral Product Development--Conducting and Submitting Virology
Studies to the Agency to assist sponsors in the development
of antiviral drugs and biological products (i.e., therapeutic proteins
and monoclonal antibodies) from the initial pre-IND through the new drug
application (NDA) and postmarketing stages. The guidance describes what
nonclinical and clinical virology data are important to support the submission
of an Investigational New Drug Application (IND), New Drug Application
(NDA), or Biologics License Application (BLA) for approval of an antiviral
product. Focusing on nonclinical and clinical virology study reports,
the guidance provides recommendations for collecting and submitting resistance
data to the Food and Drug Administration (FDA). Nonclinical and clinical
virology study reports, based on collected data, are essential for FDA's
review of antiviral drug investigational and marketing applications.
Specific topics discussed in the guidance include:
- Defining the mechanism of action
- Establishing specific antiviral activity of the investigational product
- Assessing the potential for antagonism of other antiviral products
that might be used in combination with the investigational product
- Providing data on the development of viral resistance to the investigational
product
- Providing data that identify cross-resistance to approved antiviral
products having the same target
You can view the guidance and its various attachments on the FDA web site:
- On June 22, 2006 FDA granted tentative approval to generic lamivudine,
oral solution, 10 mg/mL manufactured by Cipla Limited, Mumbai,
India, for purchase under the President's Emergency Plan for AIDS Relief
(PEPFAR).
- Prezista (darunavir), was granted accelerated approval by
FDA on June 23, 2006. Prezista, a protease inhibitor, manufactured for Tibotec,
Inc., Division of Ortho Biotech Products, L.P., Raritan, N.J., by JOLL, Gurabo,
Puerto Rico, co-administered with a low-dose of ritonavir, in combination
with other active anti-HIV agents was approved for treatment experienced
adults whose infection with HIV does not respond to treatment with other
antiretroviral drugs.
- FDA, on June 27, 2006, granted tentative approval for stavudine
15 and 20 mg capsules manufactured by Aurobindo Pharma Limited
Inc., of Hyderabad, India. A generic version of the approved Zerit brand
of the product manufactured by Bristol Myers-Squibb, tentative approval
made the generic formulation available for purchase under the President's
Emergency Plan for AIDS Relief program for use outside the U.S.
- On June 27, 2006, FDA granted tentative approval for Abacavir Sulfate
Oral Solution, 20 mg/mL, manufactured by Aurobindo Pharma Limited
Inc., of Hyderabad, India. A generic version of the approved Ziagen brand
of the product manufactured by GlaxoSmithKline, the application was reviewed
under expedited review provisions for the President's Emergency Plan for
AIDS Relief (PEPFAR).
- On June 30, 2006, FDA issued the first tentative approval for a
fixed-dose, three-ingredient tablet for use as a complete anti-viral treatment
of human immunodeficiency virus (HIV-1) infection in adults. The
product, (lamivudine-zidovudine-nevirapine tablet), contains the active
ingredients in the widely used antiretroviral drugs Epivir (lamivudine),
Retrovir (zidovudine) and Viramune (nevirapine). The combination tablet
is manufactured by Aurobindo Pharma Ltd. in Hyderabad, India for purchase
by the PEPFAR program. The recommended regimen for the lamivudine-zidovudine-nevirapine
tablet is one pill twice a day following an initial two week treatment
with the individual components taken individually.
- On July 10, 2006, FDA granted tentative approval for generic didanosine
tablets (chewable, dispersible, buffered), 100 mg, 150 mg and
200 mg, manufactured by Aurobindo Pharma Limited Inc., of Hyderabad, India.
This is a generic version of the approved Videx Chewable Tablets manufactured
by Bristol Myers Squibb. The application for the generic version for use
outside the U.S. was reviewed under expedited review provisions for the
President's Emergency Plan for AIDS Relief (PEPFAR).
- On July 12, 2006 FDA approved Atripla Tablets, a new fixed-dose
combination of three widely used antiretroviral drugs, to be taken in a
single tablet once a day, alone or in combination with other antiretroviral
products for the treatment of HIV-1 infection in adults. Atripla is the first
fixed dose combination available in the United States to combine two different
classes of antiviral drugs in a single pill. This "one-pill-once-a-day" product
to treat HIV/AIDS combines the active ingredients of Sustiva (efavirenz)
a Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI), with Emtriva (emtricitabine)
and Viread (tenofovir disoproxil fumarate), two Nucleoside Reverse Transcriptase
Inhibitors (NRTIs). Emtriva and Viread are also available in a fixed
dose combination known as Truvada. Atripla was the result of
an unprecedented inter-company cooperative effort between Gilead Sciences,
the manufacturer of Emtriva and Viread, with Bristol-Myers Squibb, the manufacturer
of Sustiva. Merck controls the marketing of Sustiva outside the United
States. The approval of Atripla not only makes the new fixed dose combination
available in the U.S., but also permits its purchase under the President's
Emergency Plan for AIDS Relief (PEPFAR) program.
- The Food and Drug Administration granted tentative approval on
July 26, 2006 for lamivudine/zidovudine tablets, co-packaged with abacavir
sulfate tablets, manufactured by Aurobindo Pharma Limited Inc.,
of Hyderabad, India, for treatment of HIV, . The lamivudine/zidovudine
combination is a generic formulation of the approved combination product,
Combivir, manufactured by GlaxoSmithKline, which combines the two Nucleoside
Reverse Transcriptase Inhibitors (NRTIs) in a single tablet. Abacavir sulfate,
which is also an NRTI, is a generic formulation of the approved product,
Ziagen, also manufactured by GlaxoSmithKline. The application was reviewed
under expedited review provisions for the President's Emergency Plan for
AIDS Relief (PEPFAR). The generic products can be used in countries which
fall under the PEPFAR program.
- On August 11, 2006, FDA granted tentative approval, for generic
nevirapine tablets, 200 mg, manufactured by Strides Acrolab Ltd.,
Bangalore, India, under the expedited review provisions created for
the President's Emergency Plan for AIDS Relief (PEPFAR) for availability
in PEPFAR-affected countries.
- The Food and Drug Administration, on August 23, 2006, granted tentative
approval for a fixed dose tablet containing generic lamivudine/zidovudine
150 mg/300 mg, manufactured by Pharmacare Limited of South Africa.
The tablets are indicated for use in combination with other antiretroviral
agents for the treatment of HIV-1 infection in adults. Tentative approval
means that FDA has concluded that a drug product has met all of the required
quality, safety and efficacy standards, though it may not be marketed in
the U.S. due to existing patents and/or exclusivity rights. However, tentative
approval makes the product eligible to be considered for purchase under
the President's Emergency Plan for AIDS Relief (PEPFAR) program. The lamivudine/zidovudine
fixed dose combination tablets are a version of the FDA approved Combivir
tablets manufactured by GlaxoSmithKline.
- On August 28, 2006, FDA granted tentative approval for stavudine
capsules, 30 mg and 40 mg, manufactured by Strides Acrolab Ltd.,
Bangalore, India, under the expedited review provisions created for the
President's Emergency Plan for AIDS Relief (PEPFAR). Tentative approval
qualifies the product for consideration for purchase under the PEPFAR program.
The tentative approval covers a generic version of Zerit Capsules, 30 mg
and 40 mg, a nucleoside reverse transcriptase inhibitor (NRTI) used in
combination with other antiretroviral agents for the treatment of HIV-1
infection, manufactured by Bristol-Myers Squibb.
- On September 13, 2006, FDA granted tentative approval for a fixed
dose tablet containing lamivudine/zidovudine 150 mg/300 mg manufactured
by Cipla Limited of Mumbai, India. The tablets are indicated for use in
combination with other antiretroviral agents for the treatment of HIV-1
infection in adults. Tentative approval makes the product eligible to be
considered for purchase under the President's Emergency Plan for AIDS Relief
program, even though patent exclusivity makes them ineligible for sale
in the U.S. The lamivudine/zidovudine fixed dose combination tablets are
a version of the approved Combivir tablets manufactured by GlaxoSmithKline.
- The Food and Drug Administration, on October 5, 2006, announced approval
of the APTIMA(r) HIV-1 RNA Qualitative Assay, manufactured by
Gen-Probe Incorporated of San Diego, California, for use in clinical laboratories
and public health facilities to detect primary (early) HIV-1 infection.
The APTIMA® HIV-I RNA Qualitative Assay is an in vitro nucleic acid
test (NAT) for the detection of human immunodeficiency virus (HIV-1) in
human plasma intended for use as an aid in the diagnosis of HIV-I infection,
including acute or primary infection, before the appearance of antibodies
to HIV-1. The newly approved test may provide earlier diagnosis of infection
than traditional detection and diagnosis of HIV-I infection by enzyme immunoassay
(EIA) because it detects nucleic acid of the human immunodeficiency virus
(HIV-1) in human plasma, rather than the body's antibody response to the
virus. The APTIMA test can also be used instead of the traditional Western
blot test or IFA for confirmation of HIV-1 infection when the screening
test result for HIV-1 antibodies is positive.
- FDA, on October 5, 2006, granted tentative approval for didanosine
for Oral Solution (Pediatric Powder), 10 mg/mL, manufactured by
Aurobindo Pharma Limited Inc., of Hyderabad, India. A generic version of
the approved Videx Pediatric Powder for Oral Solution, 10 mg/mL, manufactured
by Bristol Myers Squibb, the application was reviewed under expedited review
provisions for the President's Emergency Plan for AIDS Relief (PEPFAR).
- On October 16, 2006, the Food and Drug Administration approved
a new 300 mg capsule form of Reyataz (atazanavir) adding to the
available 100mg, 150 mg, and 200 mg capsules. The new 300 mg capsules give
treatment-experienced patients the option to take either one 300 mg capsule,
or two 150 mg capsules of Reyataz, once daily plus ritonavir 100 mg once
daily, with food. The recommended dose for treatment-naïve patients
remains unchanged and is Reyataz 400 mg (two 200mg capsules) once daily
with food. Reyataz is a product of Bristol-Myers Squibb.
- FDA announced, on October 18, 2006, the availability of guidance for industry
entitled "Fixed Dose Combinations (FDC), Co-Packaged Drug Products and
Single Entity Versions of Previously Approved Antiretrovirals for the Treatment
of HIV." The guidance encourages sponsors to develop various drug product
versions of previously approved antiretroviral drugs and to submit drug applications
for these products to FDA for review. The availability of a wide range
of safe and effective antiretroviral drug products is hoped to facilitate
a wider distribution of anti-HIV drugs to better meet the demands of the
global HIV/AIDS pandemic. The draft version of this guidance entitled "Fixed
Dose Combination and Co-Packaged Drug Products for Treatment of HIV," was
first posted on May 2004. The guidance was updated to address public comments
to the draft version. Significant changes to the draft include: 1)
the inclusion of single entity versions, in addition to combination products,
in the expedited FDA review pathway for these products 2) the addition of
tables that supply references supporting the clinical efficacy and safety
of antiretroviral combinations 3) the inclusion of more details and clarification
on the amount and type of data that should be submitted in a drug application
to support a potential approval or tentative approval. You can read the
guidance on the FDA web site (PDF 343 KB).
- On November 6, 2006, FDA granted tentative approval for a generic
formulation of abacavir sulfate tablets, 300 mg, manufactured
by Cipla Limited of Mumbai, India. The application was reviewed under the
expedited review provisions of the President's Emergency Plan for AIDS
Relief (PEPFAR). Although existing patents and/or exclusivity prevent marketing
of this product in the United States, the product met all of the safety,
efficacy, and manufacturing quality standards required for marketing in
the U.S., and can thus be considered for purchase under PEPFAR.
- On November 17, 2006, FDA granted tentative approval for a new
fixed drug combination of stavudine/lamivudine/nevirapine tablets manufactured
by Cipla Limited, of Mumbai, India. This product was reviewed under expedited
procedures for the President's Emergency Plan for AIDS Relief (PEPFAR)
program, although it cannot be marketed in the U.S. because of existing
patents and exclusivities. Stavudine, lamivudine, and nevirapine are anti-viral
drugs for the treatment of HIV-1 infection. This new combination
can significantly decrease pill burden and could result in improved compliance
for HIV infected individuals.
2007
- On January 20, 2007, the Food and Drug Administration (FDA) granted tentative
approval for a new fixed drug combination of lamivudine/stavudine (150mg/ 30mg
or 150mg/40mg) tablets manufactured by Cipla Limited, of Mumbai, India. This
product was reviewed under expedited procedures for the President's Emergency
Plan for AIDS Relief (PEPFAR) program.
- In January, the Sustiva (efavirenz) package
insert was updated to include drug-drug interaction information regarding
coadministration of efavirenz with rifampin, diltiazem, itraconazole, voriconazole,
atorvastatin, pravastatin, simvastatin, pimozide and bepredil.
- In January, additions were made to the Fuzeon (enfuvirtide)
for injection product label to include important information about nerve
bundle pain, hematoma, and cautionary wording regarding Biojector use in
patients with coagulopathy.
- On January 31, 2007, FDA granted tentative
approval for a fixed-dose, three-drug tablet for use as a complete anti-viral
treatment of HIV-1 infection in adults.
The tablet contains lamivudine-zidovudine-nevirapine, the active ingredients
in the widely used antiretroviral drugs Epivir (lamivudine), Retrovir (zidovudine)
and Viramune (nevirapine). The new combination tablet is manufactured by
Cipla Limited, of Mumbai, India.
- FDA and Bristol-Myers Squibb notified healthcare professionals in February
of revisions to the MICROBIOLOGY/Antiviral Activity and INDICATIONS AND
USAGE/Description of Clinical Studies/Special Populations sections of
the prescribing information for Baraclude (entecavir), a nucleoside analog
used in the treatment of chronic hepatitis B virus (HBV), reflecting
a case report in which a human immunodeficiency virus (HIV) variant containing
the M184V resistance substitution was documented during Baraclude treatment
for HBV infection in an HIV/HBV co-infected patient who was not simultaneously
receiving highly active antiretroviral therapy (HAART).
- On March 2, 2007, FDA granted tentative approval for a fixed dose tablet
containing lamivudine/zidovudine(150 mg/300 mg) tablets, co-packaged
with Nevirapine(200 mg tablets for the treatment of HIV-1 infection,
manufactured by Strides Arcolab Ltd, Bangalore, India, for use by the
PEPFAR Program.
- In March, FDA issued final guidance, entitled "Guidance
for Industry: Eligibility Determination for Donors of Human Cells, Tissues,
and Cellular and Tissue-Based Products (HCT/Ps)," to assist establishments making
donor eligibility determinations to comply with the requirements for
determining donor-eligibility, including donor screening and testing
for donors of human cells, tissues, and cellular and tissue-based products.
(for background, The document provides guidance on donor-eligibility determination,
donor screenings, donor testing requirements (including HIV), additional
screening and testing requirements for reproductive cells and tissues, and
exceptions from the requirements for determining donor-eligibility, and special
circumstances.
- On March 8, 2007, FDA granted approval for generic didanosine for oral solution (Pediatric Powder), 10 mg/mL, a generic version of the already FDA approved Videx Pediatric Powder for Oral Solution, 10 mg/mL, manufactured by Bristol Myers Squibb, packaged in 2 gram and 4 gram containers, manufactured by Aurobindo Pharma Limited, of Hyderabad, India, allowing marketing of the generic in United States.
- On March 9, 2007, FDA issued a public health advisory outlining new safety information, including revised product labeling about erythropoiesis-stimulating agents (ESAs), widely-used drugs for the treatment of anemia in a variety of conditions, anemia due to zidovudine therapy in HIV patients.
- On March 13, 2007, FDA granted tentative approval for two applications for antiretroviral drugs products made by Strides Acrolab Ltd., Bangalore, India, under the expedited review provisions created by FDA for the President's Emergency Plan for AIDS Relief (PEPFAR). The first was a fixed dose combination of stavudine/lamivudine (40mg/150mg) tablets, co-packaged with nevirapine tablets (200mg) for use in HIV-1 treatment of HIV-1. The second was a fixed dose combination of Stavudine/Lamivudine (40mg/150mg) Tablets for use in HIV-1 treatment in combination with other antiretroviral drugs. These drug combinations can significantly decrease pill burden and could result in improved compliance for HIV infected individuals.
- FDA granted tentative approval on March 19, 2007 for lamivudine tablets (150 mg), manufactured by Matrix Laboratories, Inc., of Hyderabad, India, under expedited review provisions developed for the President's Emergency Plan for AIDS Relief (PEPFAR).
- On March 26, 2007, FDA granted tentative approval for a generic drug formulation of efavirenz tablets (600 mg), manufactured by Strides Acrolab Ltd., Bangalore, India, under the expedited review provisions created by FDA for the President's Emergency Plan for AIDS Relief, for purchase under the PEPFAR Program.
- On April 5, 2007, FDA granted tentative approval for abacavir sulfate tablets, 300 mg, manufactured by Matrix Laboratories, Inc., of Hyderabad, India, under expedited review provisions developed to permit the tentatively approved drug's use under the President's Emergency Plan for AIDS Relief
- In April, Product labeling for KALETRA lopinavir/ritonavir) was been updated to reflect safety and efficacy data from study M97-720 in treatment-naïve patients out to 360 weeks.
- FDA granted tentative approval on April 23, 2007 for a generic formulation
for stavudine capsules, 30 mg and 40 mg, manufactured by Matrix Laboratories
Limited of Hyderabad, India, under expedited review provisions developed for
to permit use of the lower priced generic formulation by the President's Emergency
Plan for AIDS Relief.
- FDA granted approval, on May 23, 2007, to a generic formulation of zidovudine capsules, 100 mg, manufactured by Cipla Limited, of Mumbai, India, making this generic zidovudine capsules formulation available for marketing in the United States.
- On May 11/2007, FDA granted marketing approval for the Abbott RealTime HIV-1
Assay, made by ABBOTT Molecular, Inc., an in vitro reverse transcription-polymerase
chain reaction (RT-PCR) assay for the quantitation of Human Immunodeficiency
Virus type 1 (HIV-1) on the automated m2000 System in human plasma from HIV-1
infected individuals over the range of 40 to 10,000,000 copies/mL, for use
in managing the treatment of HIV infection. The Abbott RealTime HIV-1 assay
is intended for use in conjunction with clinical presentation and other laboratory
markers for disease prognosis and for use as an aid in assessing viral response
to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels.
- On May 11/2007, FDA granted marketing approval for the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, made by Roche Diagnostics. The automated PCR test, indicated for the quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) nucleic acid in human plasma (viral load) for use in conjunction with clinical presentation and other laboratory markers for the clinical management of HIV-1 infected patients. It can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in plasma HIV-1 RNA levels during the course of antiretroviral treatment.
- On May 23, 2007, FDA approved the Procleix Ultrio Assay on the fully automated
Procleix TIGRIS system manufactured by Gen-Probe Inc., of San Diego, California,
and marketed by Chiron Corporation, a fully automated qualitative in vitro
nucleic acid test (NAT) to screen for human immunodeficiency virus type 1 (HIV-1)
and hepatitis C virus (HCV) RNA in donated blood from donors of whole blood,
blood components, or source plasma. It is also licensed to screen individual
organ donations from living donors, heart-beating organ donors, and cadaveric
(non-heart-beating) organ donors. The capability of full automation will reduce
human error and accelerate blood screening, enhancing blood safety.
- On June 14, 2007, the Food and Drug Administration approved a new formulation of Lexiva (fosamprenavir calcium), available as an oral suspension (50-mg/mL). The package insert was updated to include information on the new formulation and to provide dosing information for pediatric patients and patients with hepatic impairment
- FDA granted tentative approval on July 10, 2007 for a generic formulation of nevirapine tablets, 200 mg, manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. of Zhejiang China, under expedited review provisions developed for the President's Emergency Plan for AIDS Relief for us of the generic formulation by that international relief program.
- On July 12, 2007 FDA granted tentative approval for a generic formulation
of efavirenz tablets, 600 mg, manufactured by Matrix Laboratories Limited,
of Hyderabad, India, under expedited review provisions developed to allow
purchase of this generic formulation by the President's Emergency Plan for
AIDS Relief.
- FDA approved revised labeling on July 24, 2007 for BARACLUDE (entecavir) 0.5 mg and 1.0 mg Film-Coated Tablets, and BARACLUDE (entecavir) 0.05 mg/mL Oral Solution for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. The amended label includes safety information related to the use of entecavir (ETV) in patients with human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfection who are not receiving simultaneous highly active antiretroviral therapy (HAART).
- On August 6, 2007, the Food and Drug Administration (FDA) approved Selzentry (maraviroc) 150 mg and 300 mg tablets, the first drug in the new class of anti-HIV medications called CCR-5 co-receptor antagonists, under a priority review. CCR-5 co-receptor antagonist are used in combination with other antiretroviral products for the treatment of adults infected with CCR5-tropic HIV-1.
- FDA granted tentative approval on August 8, 2007 for a generic formulation of a combination product consisting of lamivudine and zidovudine tablets,150 mg/300 mg, manufactured by Emcure Pharmaceuticals Inc. of Pune, India under expedited review provisions developed to permit purchase of this generic product by the President's Emergency Plan for AIDS Relief overseas.
- FDA granted tentative approval on August 8, 2007 for a generic formulation of a combination product, lamivudine and zidovudine tablets,150 mg/300 mg, manufactured by Emcure Pharmaceuticals Inc. of Pune, India under expedited review provisions developed to allow purchase by the President's Emergency Plan for AIDS Relief for treatment use in the countries covered by the AIDS relief program.
- FDA, on August 13, 2007, granted tentative approval for a new fixed dose three-drug combination pill containing generic lamivudine, stavudine and nevirapine, to treat human immunodeficiency virus (HIV-1) infection in children outside the United States. This was the first combination of its kind available to meet the needs of children less than 12 years of age, and represents a major advance in global AIDS treatment efforts. The generic combination drug tablet is manufactured by Cipla Limited, of Mumbai, India.
- On October 4, 2007, FDA granted traditional approval to Aptivus (tipranavir),
for combination antiretroviral treatment of HIV-1 infected adults with evidence
of viral replication, who are treatment-experienced and infected with HIV-1
strains resistant to more than one protease inhibitor. Aptivus, a product of
Boehringer Ingelheim, was granted accelerated approval on June 22, 2005, based
on analysis of plasma HIV-1 RNA levels in two controlled phase 3 studies of
24 weeks duration of Aptivus/ritonavir. The traditional approval was based
on continuation of the RESIST trials through 48 weeks and beyond, confirming
durability of the virologic response.
- On, October 12, 2007, FDA granted accelerated approval for raltegravir tablets (400 mg) to treat Human Immunodeficiency Virus (HIV)-1 infection in combination with other antiretroviral agents. Raltegravir, with the trade name Isentress, was the first approved product in the pharmacological class of antiretroviral agents known as HIV integrase strand transfer inhibitors, commonly referred to as integrase inhibitors. They are designed to slow the advancement of HIV-1 infection by blocking the HIV integrase enzyme that the virus needs in order to multiply. Raltegravir received a priority review by the FDA. The review and approval of the New Drug Application was completed in within six months.
- On October 12, 2007, FDA approved a supplemental new drug application for Lexiva (fosamprenavir calcium; FPV) Oral Tablets, adding a new indication for once-daily dosing of 1400 mg of Lexiva with 100 mg ritonavir for the treatment of HIV infection in therapy-naïve adults.
2008
- On January 19, During 2008, FDA granted accelerated approval for etravirine
100 mg tablets, the first non-nucleoside reverse transcriptase inhibitor
(NNRTI) to demonstrate antiviral activity in patients with NNRTI-resistant
virus, with the trade name Intelence.
- On February 5, a new 600 mg tablet strength of the protease inhibiotor
Prezista (darunavir) was approved to reduce pill burden and thus facilitate
dosing.
- On March 27, 2008, FDA approved a new HIV diagnostic test, the VITROS Anti-HIV
1+2 assay for diagnosis and donor screening for antibodies to human
immunodeficiency virus types 1 and 2 in human serum and plasma.
- On July 18, 2008, FDA approved changes to the package insert for Ziagen
(abacavir sulfate) highlighting important information about the association
of the HLA-B*5701 allele (a part of a gene) and hypersensitivity reactions
(HSR) caused by abacavir-containing therapy, and recommending screening patients
for the HLA-B*5701 allele prior to initiating or reinitiating abacavir-containing
therapy. Prospective screening for HLA-B*5701 and selection of alternative
therapy for subjects who carry this allele to reduce the incidence of abacavir
hypersensitivity (HSR) reaction and improve the safety profile of this drug.
- FDA also approved changes in the Reyataz (atazanavir) package insert
to include important drug-drug interaction information regarding
the administration of Reyataz with or without ritonavir and nevirapine, efavirenz,
hormonal contraceptives, orally and parenterally administered midazolam,
H2-receptor antagonists and drugs that are substrates of cytochrome
P450 2C8.
- On August 29,
FDA approved changes to the product label for Norvir
(ritonavir) Soft Gelatin Capsules, and Norvir Oral Solution reflecting
new post marketing information regarding QT/QTc interval and PR interval
prolongation information from Study M06-80.
The patient package insert was updated, as well, with language related
to electrocardiogram changes and cardiac arrhythmias.
- On September 19, FDA approved a pediatric efficacy supplement for
Retrovir syrup, capsules and tablets allowing for a twice daily dosing regimen
in children 6 weeks to 18 years of age, and provided for dosing by weight
in addition to dosing by body surface area.
- On September 29, 2008, FDA approved a pediatric efficacy supplement for
Videx EC (didanosine) Delayed-Release Capsules, expanding the indication
to include children weighing at least 20 kg.
- On September 30, 2008, FDA approved an alternative dosing regimen for Reyataz
(atazanavir) for HIV-1 infected treatment-naïve patients who can take
ritonavir.
- On October 21, FDA granted traditional approval to Prezista (darunavir)
600 mg, co-administered with 100 mg ritonavir and with other antiretroviral
agents, for the treatment of HIV-1 infection in treatment-experienced adult
patients a 48 week phase 3 study
in treatment-experienced patients and continuation of two controlled trials
of 96 weeks duration in clinically advanced, treatment-experienced patients,
confirming durability of the virologic response.
- On October 21,FDA also approved a new dosing regimen
for Prezista (darunavir) with ritonavir
100 mg once daily for treatment-naïve patients
- On November 10, FDA published a final
rule amending the classification regulation for male condoms made of natural
rubber latex (latex condoms) and latex condoms with spermicidal lubricant
containing nonoxynol-9 (N-9), designating specific guidance containing
labeling recommendations as a special control for latex condoms. (Effective
date; January 9, 2009)
- On November 25, FDA granted full, traditional approval for the use
of maraviroc in treatment-experienced patients infected with CCR5-tropic
HIV-1. The change from accelerated to traditional approval was based on 48
week data from two double-blind, randomized, placebo-controlled,multicenter
studies in subjects infected with CCR5-tropic HIV-1.
- On December 18, FDA approved new pediatric dosing recommendations
for a new 75 mg Prezista (darunavir) tablet formulation for patients from
6 to less than 18 years of age.
- On December 19, FDA approved Ziagen (abacavir) 300 mg scored tablets with
corresponding dosing information for pediatric patients weighing 14 kg or
more using the scored tablet.
- On December 30, FDA approved the first nucleic acid test (NAT) to detect
the presence of two less common types of HIV in donated blood plasma and
human tissue. cobas TaqScreen MPX Test detects nucleic acid from HIV-2 and
from HIV-1 Group O, as well as the more common HIV-1 Group M, and Hepatitis
C and B virus.
- During 2008 FDA approved six generic HIV medications
for the U.S. market; zidovudine tablets 300 mg, zidovudine oral solution
50 mg/5mL, didanosine delayed release capsules, 125 mg, 200 mg, 250 mg
and 400 mg and stavudine for oral solution 1 mg/mL and
stavudine capsules 15 mg, 20 mg, 30 mg, and 40 mg (2 approvals).
- Tentative approvals were granted during 2008 under expedited review procedures
for the President's Emergency Fund for AIDS Relief (PEPFAR)
for the following drugs: efavirenz (2 tentative approvals), lamivudine (2 tentative
approvals), abacavir sulfate 60 mg scored tablet for pediatric dosing, emtricitabine
capsules (2 tentative approvals), nevirapine tablets, stavudine tablets, and
atazanavir sulfate capsules.
- During 2008 the following 5 fixed-dose combinations were granted tentative
approval under expedited review procedures for PEPFAR: abacavir
sulfate and lamivudine (2 tentative approvals), lamivudine/stavudine tablets
for pediatric dosing, stavudine/ lamivudine/nevirapine 30mg/150mg/200mg Tablets,,
and stavudine/lamivudine/nevirapine 40mg/150mg/200mg Tablets
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