HIV and AIDS
Human Immunodeficiency Virus and
Acquired Immunodeficiency Syndrome
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FDA HIV/AIDS E-mail List
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This e-mail list provides one source for FDA HIV/AIDS related information
on a variety of topics, including:
- product approvals
- significant labeling changes
- safety warnings
- notices of upcoming public meetings
- proposed regulatory guidances and opportunity to comment
Join
the FDA HIV/AIDS e-mail list
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the information: 2008 | 2007 | 2006 |
2005 | 2004 | 2003 | 2002
- Tentative approval
of abacavir sulfate and lamivudine tablets, 600 mg/300 mg 9/3/2008
- Updated labeling
for Norvir (ritonavir) soft capsule and oral solution 9/2/2008
- Important updates
to the Reyataz (atazanvir) label 8/21/2008
- Revised Pediatric
Treatment Guidelines 8/7/2008
- Important safety-related
label update for Ziagen (abacavir sulfate) 7/23/2008
- Zidovudine Oral Solution USP, 50 mg/5
mL generic product approval 6/27/2008
- Important changes to Viramune (nevirapine)
oral solution and tablets 6/27/2008
- New pediatric dosing for Aptivus, patients
2-18 years, New Oral Solution and info on coadministration with midazolam 6/23/2008
- New pediatric dosing information for
Kaletra, patients 14 days to 6 months and 12-18 years of age and update
information on coadministration with midazolam 6/23/2008
- Tentative approval:
Fixed dose combination of generic lamivudine/stavudine tablets for pediatric
dosing 6/20/2008
- Report of false-positive
oral fluid rapid HIV test results 6/20/2008
- Recent updates
to Invirase package insert 6/11/2008
- Tentative approval
of generic emtricitabine capsules 5/21/2008
- Tentative approval
of generic nevirapine tablets 5/16/2008
- Approval of VITROS
Anti-HIV 1+2 diagnostic immunoassay 3/28/2008
- Early Communication
about an Ongoing Safety Review of Ziagen (Abacavir) and Videx (Didanosine) 3/27/2008
- New pediatric
dosing recommendations for Reyataz Capsules, patients ages 6 to 18 years
old 3/26/2008
- Tentative approval
of two fixed dose combination products for PEPFAR 3/24/2008
- Dear Healthcare
Professional letter regarding new prescribing information for Prezista
(darunavir) 3/12/2008
- Updates to Prezista
(darunavir) tablets labeling 3/11/2008
- Tenative approval of generic efavirenz tablets,
600 mg 3/3/2008
- Tentative approval
of generic stavudine tablets, 15 mg, 20 mg, 30 mg, and 40 mg 3/3/2008
- Updated Pediatric
Treatment Guidelines available 2/29/2008
- New 600 mg tablet
strength for Prezista (darunavir) 2/26/2008
- Approval of generic
zidovudine tablets, 300 mg 2/14/2008
- Tentative approval
of generic atazanavir sulfate capsules 2/8/2008
- New Epivir tablets
to facilitate pediatric dosing 2/7/2008
- Tentative approval
of generic lamivudine 1/29/2008
- Guidelines for
the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
updated 1/29/2008
- Approval of etravirine
for treatment-experienced adult patients 1/18/2008
- Reyataz (atazanavir)
package insert revisions 1/16/2008
- Approval of Multispot
HIV-1 / HIV-2 Rapid Test 12/30/2004
- Crixivan (indinavir)
label revised ~ Not recommended for HIV-infected pregnant patients 12/27/2004
- Atazanavir, with
or without ritonavir should not be coadministered with proton pump inhibitors 12/20/2004
- New 500 mg
Tablet Formulation of Invirase (saquinavir) Approved 12/17/2004
- Approval of Generic
ddI 12/3/2004
- Guidelines for
the Use of Antiretroviral Agents in Pediatric HIV Infection Update 12/1/2004
- World AIDS Day 12/1/2004
- Draft Guidance:
Role of HIV Drug Resistance Testing in Antiretroviral Drug Development 11/26/2004
- Final Guidance: Use
of Nucleic Acid Tests for Blood Screening for HIV-1 and HCV 11/17/2004
- Dear Healthcare
Provider letter regarding early virologic failures on Videx/Viread 11/12/2004
- Availability
of Revised HIV Treatment Guidelines 10/29/2004
- Fuzeon (enfuvirtide,
T-20) Accelerated to Traditional Approval / Label Revisions 10/22/2004
- Kaletra (lopinavir
and ritonavir) Labeling Revisions 10/22/2004
- Exploring Scientific
Opportunities for Facilitating Development of Vaccines, Blood and Blood Products,
and Cellular, Tissue, and Gene Therapies 9/14/2004
- Meeting of FDA's
Vaccines and Related Biological Products Advisory Committee 9/8/2004
- Sustiva labeling
revisions 8/17/2004
- FDA approval of
Sculptra for treating facial lipoatrophy8/3/2004
- Two new Fixed Dose
Combinations Approved 8/2/2004
- New HIV/AIDS Advisory
Committee Records Web Page 7/27/2004
- New Dosing Regimen
for REYATAZ/ritonavir in Treatment-Experienced Patients 7/7/2004
- VIREAD (tenofovir
disoproxil fumerate) Label Update 7/6/2004
- CLIA Waiver granted
to OraQuick ADVANCE Rapid HIV-1/2 Antibody Test 7/2/2004
- Desyrel (trazodone
hydrochloride) and CYP3A4 Inhibitors - ketoconazole, ritonavir, and indinavir 5/21/2004
- New Rule and Draft
Guidance Issued for Human Cell and Tissue Donor Screening 5/20/2004
- FDA Defines Process
for Expedited Approval of Co-Packaged and Fixed Dose Combination HIV Therapies 5/17/2004
- Changes to
Crixivan (indinavir sulfate) capsules product label and patient package insert 5/12/2004
- Labeling changes
for Voriconazole (VFEND) antifungal, when coadministered with efavirenz or
ritonavir 5/4/2004
- FDA Approval
of Generic Ribavirin for Treatment of Chronic Hepatitis C 4/7/2004
- 3 issues related
to Rapid Testing for HIV 3/26/2004
- Updated Guidelines
for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents 3/23/2004
- Revised Pediatric
Dosing Recommendations for Viracept (nelfinavir) 3/22/2004
- Important new
information about atazanavir drug interaction 3/19/2004
- Advisory Committee
review of an injectable device intended for use in correction of lipoatrophy
of the face in HIV positive patients 3/2/2004
- Changes to Crixivan
Labeling 1/13/2004
- FDA Approval
of New, 10 Minute Rapid HIV Test 1/2/2004
This list serve was created by the FDA Office of Special Health Issues (Office
of the Commissioner) and the Division of Antiviral Drug Products (Center for
Drug Evaluation and Research) in February 2002.
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