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CDER News Items 2003
December 30, 2003
- The prescribing information for Topamax (topiramate/topiramate
capsules) has been revised to include a warning that Topamax causes
hyperchloremic, non-anion gap metabolic acidosis (decreased serum
bicarbonate).
MedWatch Safety Info.
December 22, 2003
- FDA and Lilly modified the label for Permax (pergolide mesylate)
to inform healthcare professionals of the possibility of patients
falling asleep while performing daily activities, including
operation of motor vehicles, while receiving treatment with Permax.
MedWatch Safety Info.
December 10, 2003
- FDA approves Ertaczo (sertaconazole nitrate) Cream, 2%, for the
topical treatment of interdigital tinea pedis in immunocompetent
patients 12 years of age and older.
December 9, 2003
- FDA is amending its regulations to require electronic submission
of labeling for review with new drug applications (NDAs), certain
biological license applications (BLAs), abbreviated new drug
applications (ANDAs), supplements, and annual reports.
FDA
News
Final
Rule
December 8, 2003
- Magno-Humphries, Inc., in cooperation with the FDA, voluntarily
recalls one lot of Dixon's, APAP Acetaminophen 325 mg Analgesic
Tablets, an OTC drug product. The recall is effective immediately
because the lot contains an excess of the labeled amount of
acetaminophen.
MedWatch Safety Information.
December 4, 2003
- FDA approves Malarone (atovaquone and proguanil HCL) Tablets for
the treatment of P. falciparum malaria in pediatric patients.
November 25, 2003
November 24, 2003
- Aventis Pharmaceuticals and FDA updated the prescribing
information for Arava (leflunomide), indicated for the treatment of
active rheumatoid arthritis.
MedWatch Safety Information.
November 21, 2003
- FDA approves Cialis (tadalafil), an oral medication to treat
erectile dysfunction (ED), or impotence, in men.
Cialis Information
November 20, 2003
- Abbott Laboratories issues a "Dear Healthcare Professional"
letter concerning reports of fire or extreme heat in the respiratory
circuit of anesthesia machines when Ultane is used in conjunction
with a desiccated CO2 absorbent. MedWatch
Safety Information.
November 16, 2003
- FDA and the National Cancer Institute (NCI) announce two new
collaborative initiatives to facilitate the development and use of
better cancer treatments.
NCI News.
November 14, 2003
- FDA alerts U.S. residents to the recent recall of certain
GlaxoSmithKline "Diskus" medicines sold in Canada to treat asthma
and chronic obstructive pulmonary disease (COPD).
FDA Talk Paper.
- FDA approves Ovcon 35 as the first chewable oral contraceptive
tablet for women.
FDA Talk Paper.
November 6, 2003
- FDA Calls CanaRx's Drug Sales Illegal, Risk to Public.
FDA
News.
November 3, 2003
- FDA issues Draft Guidance for Industry: Pharmacogenomic Data
Submissions. The Guidance encourages drug and biologic developers to
conduct pharmacogenomic tests during drug development.
FDA News Draft Guidance
October 28, 2003
- FDA approves Raptiva (efalizumab) for the treatment of adults
with moderate to severe chronic plaque psoriasis who are candidates
for systemic therapy or phototherapy.
- FDA warns consumers that use of the synthetic steroid
tetrahydrogestrinone (THG) may pose considerable risks to health.
THG is reportedly used by athletes to improve their performance.
FDA
Statement.
October 27, 2003
- FDA issues a Public Health Advisory to alert physicians to
reports of suicidal thinking (and suicide attempts) in clinical
studies of various antidepressant drugs in pediatric patients with
major depressive disorder (MDD).
FDA Talk Paper. FDA Public
Health Advisory.
October 20, 2003
October 17, 2003
- FDA proposes new steps to assure the safety and efficacy of
certain unapproved, but widely marketed medicines.
FDA
News.
- FDA approves Namenda (memantine) for treatment of moderate to
severe Alzheimer’s Disease. This is the first drug approved for the
treatment of patients with this severity of disease.
FDA
News.
October 10, 2003
- FDA approves Estrasorb (estradiol topical emulsion) for the
treatment of menopausal hot flashes.
FDA Talk Paper.
October 8, 2003
- FDA approves of Inspra (eplerenone) tablets for improving the
survival of congestive heart failure patients following an acute
heart attack.
FDA Talk Paper.
October 2, 2003
- FDA approves Radiogardase, also known as Prussian blue, to treat
people exposed to radiation contamination, due to harmful levels of
cesium-137 or thallium.
Prussian Blue
Information.
September 29, 2003
- FDA releases a Public Health Advisory advising healthcare
practitioners to be aware that use of FD&C Blue No. 1 (Blue
1)-tinted enteral feedings for detecting aspiration has been
associated with several serious adverse events, including death,
although a direct causal relationship has not been definitely
established.
FDA Public Health Advisory.
- Novo Nordisk and FDA revise the Precautions/Drug Interaction
section of the prescribing information to inform healthcare
professionals of a drug-drug interaction between repaglinide
(Prandin), a short-acting insulin secretagogue, and gemfibrozil
(Lopid) a lipid-lowering agent used to treat dyslipidemia.
MedWatch Safety Information.
September 22, 2003
- FDA expands the indication of Palivizumab to include children
with hemodynamically significant congenital heart disease.
September 12, 2003
- FDA announces the approval of Cubicin (daptomycin for injection)
for the treatment of complicated skin and skin structure infections.
Cubicin is the first approved product in a new class of antibiotics
called cyclic lipopeptide antibacterial agents.
FDA Talk Paper.
September 9, 2003
- Roxane Laboratories, Inc. is discontinuing the sale and
distribution of Orlaam, a synthetic opioid agonist solution
indicated for the management of opiate dependence.
MedWatch Safety Information.
- FDA takes action against companies that are importing
unapproved, potentially unsafe drugs.
FDA
News.
September 5, 2003
- FDA approves Seasonale, a new choice in oral contraceptives for
women for prevention of pregnancy.
FDA Talk Paper.
September 4, 2003
- FDA outlines new steps in its strategic initiative to modernize
the regulation of pharmaceutical manufacturing and product quality.
Initiative Information.
August 29, 2003
- FDA clarifies its current thinking regarding standardized
medical terminology for postmarketing safety reporting. For further
information, see Q7 of the
Questions and Answers.
- FDA approves a new indication for Valtrex (valacyclovir
hydrochloride) Caplets. Valtrex reduces the risk of heterosexual
transmission of genital herpes to susceptible partners with healthy
immune systems when used as suppressive therapy in combination with
safer sex practices.
FDA Talk Paper. Label.
August 22, 2003
- FDA approves Anakinra (Kineret) for the reduction in signs and
symptoms and slowing the progression of structural damage in
moderately to severely active rheumatoid arthritis, in patients
18 years of age or older who have failed one or more disease
modifying antirheumatic drugs.
August 21, 2003
- The Drug Shortage email account (DrugShortages@cder.fda.gov) was
infected by a virus/worm and had to be shut down and completely
cleaned. More Information
- FDA and Roche revise the prescribing information for Zenapax
(daclizumab). These changes include the addition of two new warning
statements. Zenapax is indicated for the prophylaxis of acute organ
rejection in patients receiving renal transplants.
MedWatch Safety Information.
August 20, 2003
- FDA unveils a five-part strategic action plan to protect and
advance America's health.
FDA
News.
Strategic Plan.
August 19, 2003
- FDA approves Levitra (vardenafil), an oral medication to treat
erectile dysfunction in men (impotence). This is the second oral
product approved for the treatment of erectile dysfunction.
FDA Talk Paper. Label.
August 14, 2003
- FDA announces the addition of new safety information and
warnings to the labeling for drug products that contain salmeterol,
a long-acting bronchodilator used to treat asthma and chronic
obstructive pulmonary disease (COPD). The products affected by these
changes are Serevent Inhalation Aerosol, Serevent Diskus, and Advair
Diskus.
FDA Talk Paper. MedWatch
Safety Information.
August 13, 2003
- The Centers for Disease Control and Prevention (CDC) notifies
healthcare professionals of revised recommendations against the use
of rifampin plus pyrazinamide for treatment of latent tuberculosis
infection, due to high rates of hospitalization and death from liver
injury associated with the combined use of these drugs.
MedWatch Safety Information.
- FDA approved Crestor (rosuvastatin) to lower cholesterol.
Lowering cholesterol is a key to reducing the risk of heart disease.
Rosuvastatin is in the class of drugs called HMG-CoA reductase
inhibitors, also known as statins.
FDA Talk Paper.
August 12, 2003
On August 18, 2003, FDA will implement a final rule that will help
speed the approval of generic drugs and should result in billions of
dollars in health care savings for consumers.
FDA
Statement. Final
Rule
July 24, 2003
- FDA approves Enbrel (etanercept), a genetically engineered
protein, for the treatment of patients with active ankylosing
spondylitis, a chronic inflammatory disease affecting primarily the
lower back and joints.
FDA Talk Paper.
July 18, 2003
- FDA approves Premarin (conjugated estrogens) oral tablets, 0.3
and 0.45 mg, for the prevention of postmenopausal osteoporosis.
July 16, 2003
- FDA launches a major initiative to more aggressively protect
American consumers from counterfeit drugs. Counterfeit prescription
drugs are not only illegal but are also inherently unsafe.
FDA Initiative Information.
July 9, 2003
- Barr Laboratories announces a voluntary recall of three lots of
its Nortrel 7/7/7 - 28 day (norethindrone and ethinyl estradiol
tablets, USP) oral contraceptive product.
MedWatch Safety Alert
- FDA announces the development of a Medication Guide
(FDA-approved patient labeling) to provide better information to
consumers about the risks and benefits of Lariam (mefloquine
hydrochloride), and to educate patients on the measures to be taken
to optimize Lariam's effectiveness. Lariam is a valuable drug in
helping to prevent malaria.
FDA
News Medication
Guide
July 3, 2003
- FDA approves Emtriva (emtricitabine), in combination with other
antiretroviral agents, for the treatment of HIV-1 infection in
adults.
June 20, 2003
- FDA approves Reyataz (atazanavir sulfate), a protease inhibitor
to be used in combination with other anti-retroviral agents for the
treatment of patients with HIV infection.
FDA Talk Paper
- AstraZeneca Pharmaceuticals LP has pleaded guilty to
illegitimate pricing and marketing of Zoladex, an AstraZeneca drug
for the treatment of prostate cancer, and agreed to pay $355 million
to resolve the associated criminal charges and civil liabilities.
FDA
News
- FDA approves new dosage forms of the Atropen (atropine
autoinjector) for use in children and adolescents exposed to certain
nerve agents or insecticides. The Atropen has been approved since
1973 for use in adults.
FDA Talk Paper
June 19, 2003
- FDA is reviewing reports of a possible increased risk of
suicidal thinking and suicide attempts in children and adolescents
under the age of 18 treated with the drug Paxil for major depressive
disorder (MDD). Although the FDA has not completed its evaluation of
the new safety data, FDA is recommending that Paxil not be used in
children and adolescents for the treatment of MDD.
FDA Talk Paper
Paxil Information
Page
June 13, 2003
- Albers Medical Distributors, Inc, in conjunction with FDA,
expands their original voluntary recall to include all lots of
Lipitor that Albers purchased, which were packaged by Med-Pro. All
lots subject to this recall are listed in the Albers June 9, 2003
press release.
Press
Release
Additional information
June 12, 2003
- FDA discusses potential post-marketing drug safety issues for
specific drugs that have received pediatric exclusivity under the
Best Pharmaceuticals for Children Act.
FDA Talk Paper
- FDA announces new regulations and review procedures to
streamline the process for making safe, effective generic drugs
available to consumers.
FDA
Press Release
June 3, 2003
- FDA announces that its continuing investigation of counterfeit
Lipitor has turned up additional counterfeit quantities of the
cholesterol-lowering drug product.
FDA Talk Paper
May 29, 2003
- Best Life International warned consumers not to purchase or
consume the product known as Viga. This product, which is being
marketed as a dietary supplement, contains the unlabeled drug
ingredient sildenafil, which may pose possible serious health risks
to some users.
MedWatch Safety Information
May 23, 2003
May 20, 2003
- FDA Approves Gleevec for Pediatric Leukemia Treatment.
FDA
Talk Paper and
Label
FDA announces Postmarketing Study Commitments
Web site.
May 13, 2003
- FDA has approved Velcade to treat a type of cancer called
multiple myeloma. Velcade is a new type of cancer drug called a
proteasome inhibitor.
Velcade Information Page
May 5, 2003
- FDA announces the approval of Iressa (genfitnib) tablets as a
single agent treatment for patients with advanced non-small cell
lung cancer, the most common form of lung cancer in the US. Iressa
is approved as a treatment for patients whose cancer has continued
to progress despite treatment with platinum-based and docetaxel
chemotherapy, two drugs that are currently the standard of care in
this disease.
Iressa Information
Page
April 16, 2003
- FDA announces changes to the labeling for Zocor (simvastatin),
The new labeling will reflect research showing that simvastatin is
effective in reducing risks of fatal and non-fatal heart attacks,
strokes, and in reducing the need for bypass surgery and
angioplasty.
FDA Talk Paper
April 11, 2003
- FDA announces the approval of revised labeling for Rapamune
(sirolimus) that will allow new kidney transplant patients at low to
moderate immunologic risk of organ rejection to stop taking
cyclosporine 2 to 4 months after transplantation.
FDA Talk Paper
Revised Rapamune Label
April 10, 2003
- FDA revises the finding on estrogen/androgen combination
products in the treatment of hot flashes.
FDA Talk Paper
April 7, 2003
- FDA approves Factive (gemifloxacin mesylate) Tablets to treat
acute exacerbation of chronic bronchitis and community-acquired
pneumonia.
April 1, 2003
- FDA issues draft guidance for Federal agencies and state and
local governments on the shelf life extension of potassium iodide
tablets.
FDA Talk Paper Draft
Guidance
March 28, 2003
- FDA announces important safety updates to the labeling of
Lindane Shampoo and Lindane Lotion for the treatment of scabies and
lice. Lindane
Information Page
March 26, 2003
- FDA announces the approval of a new drug called Emend
(aprepitant), to be used in combination with other anti-nausea and
anti-vomiting drugs for prevention of acute and delayed nausea and
vomiting associated with initial and repeat courses of chemotherapy
known to cause these problems, including high-dose cisplatin.
FDA
News
March 25, 2003
- FDA approves Somavert (pegvisomant for injection) for the
treatment of acromegaly, a potentially life threatening disease
triggered by an excess of growth hormone.
FDA
News
March 21, 2003
- FDA collaborates with the Arkansas State Board of Pharmacy in an
enforcement action against Rx Depot, Inc. for obtaining unapproved
drugs from Canada.
FDA
News
March 19, 2003
- Tai Chien Inc. recalls all 100-tablet bottles of Ancom
Anti-Hypertensive Compound Tablets, an unapproved new drug labeled
to contain several prescription drug ingredients.
FDA Safety Information
March 14, 2003
- Biogen and FDA revise sections of the prescribing information
for Avonex (Interferon beta-1a) to include important new safety
information and a patient Medication Guide.
FDA Safety Information
- FDA warns the public about misrepresentations in a SuperGen,
Inc. press release in connection with a recently approved cancer
drug, Mitozytrex (mitomycin for injection).
FDA Talk Paper
March 13, 2003
- As part of a wide-ranging effort to improve patient safety, FDA
proposes both a rule to require bar coding on almost all medications
and blood products, and significant changes to its safety reporting
requirements for medicines.
FDA Information
- FDA warns the public about misrepresentations in a SuperGen,
Inc. press release in connection with a recently approved cancer
drug, Mitozytrex (mitomycin for injection).
FDA Talk Paper
- FDA approves the first drug in a new class of HIV treatments for
HIV infected adults and children with advanced disease.
FDA
News
March 11, 2003
- FDA uncovers the existence of contaminated counterfeit Procrit,
also known as epoetin alfa.
FDA
News
February 28, 2003
- The Department of Health and Human Services (HHS) announces a
series of actions designed to protect Americans from potentially
serious risks of dietary supplement products containing ephedra.
FDA
News
February 26, 2003
- FDA issues letter discussing its enforcement policy for
unapproved drugs.
FDA Talk Paper
February 24, 2003
- Lilly and FDA revise the Permax (pergolide
mesylate) warnings section of the prescribing information to inform
healthcare professionals of reports of cardiac valvulopathy
involving one or more valves in patients receiving Permax therapy.
MedWatch Safety Information
January 31, 2003
- FDA announces a broad initiative to help make innovative medical
technologies available sooner, and to reduce the costs of developing
safe and effective medical products. FDA
News Full
Report Executive
Summary
- FDA announces conditions under which prussian blue can be found
safe and effective for the treatment of internal contamination with
radioactive cesium, radioactive thallium, or non-radioactive
thallium.
FDA
News
- FDA releases an illustration of the impact of submission trends
on median approval time statistics for New Drug Applications.
CDER Guide to Median
Approval Time Statistics.
January 23, 2003
- FDA announces that an interim analysis of a large
safety study of the approved asthma drug Serevent (salmeterol
xinafoate) Inhalation Aerosol suggests that the drug may be
associated with an increased risk of life-threatening asthma
episodes or asthma-related deaths, particularly in some patients.
FDA Talk Paper
- FDA publishes a draft Guidance for Industry to recommend
categories for collecting effectiveness and safety data during
clinical trials for ethnic and racial demographic groups.
FDA Talk Paper and Draft Guidance.
January 21, 2003
- FDA approves generic Loratadine Tablets to
relieve runny nose; sneezing; itchy, watery eyes; itching of the
nose or throat due tohay fever or other respiratory allergies.
January 17, 2003
- FDA approves Xanax XR (alprazolam) Extended-release Tablets for
the treatment of panic disorder.
- Herbsland Inc. recalled all 100 tablet bottles of Ancom
Anti-Hypertensive Compound Tablets, an unapproved new drug labeled
to contain several prescription drug ingredients, including
reserpine, diazepam, promethiazine, and hydrochlorothiazide.
FDA Safety Information
January 16, 2003
- FDA and the Substance Abuse and Mental Health Services
Administration (SAMHSA) join efforts to educate public on the
dangers of rising prescription drug
abuse.
SAMSHA News Release
- FDA proposes new warnings for the labels of over-the-counter
vaginal contraceptive drugs that contain the spermicide nonoxynol 9.
FDA Talk Paper
January 13, 2003
- FDA releases preliminary survey results on direct-to-consumer
prescription drug ads.
FDA Talk Paper
January 8, 2003
- FDA
approves new labels for hormone therapy for postmenopausal women.
Drug Information Page
- FDA approves generic
Strontium Chloride Sr-89 Injection to help relieve bone pain caused
by cancer.
January 3, 2003
- FDA approves new uses for the antidepressant Prozac (fluoxetine)
to treat children and adolescents seven to 17 years of age for
depression (major depressive disorder) and obsessive compulsive
disorder (OCD).
FDA Talk Paper
- FDA releases a searchable database for information on inactive
ingredients present in FDA-approved drug products. This information
can be used by industry as an aid in developing drug products.
Inactive Ingredient Database
- FDA approves Restasis (cyclosporine ophthalmic emulsion) to
increase tear production in patients whose tear production is
presumed to be suppressed due to ocular inflammation associated with
keratoconjunctivitis sicca.
News Items 2008
News Items 2007
News Items 2006
News Items 2005
News Items 2004
News Items 2002
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Date updated: January, 2008 |
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