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CDER News Items 2002
December 20, 2002
- FDA approves Gleevec (imatinib mesylate) for the first-line
treatment of patients with chronic myeloid leukemia (CML), an uncommon
life-threatening form of cancer affecting about 40,000 people in the
United States.
FDA News. Label.
December 19, 2002
- FDA approves over-the-counter use of Alavert (loratadine) Orally
Disintegrating Tablets for the temporary relief of symptoms of hay fever
or other upper respiratory allergies: runny nose, sneezing, itchy,
watery eyes, and itching of the nose or throat.
FDA approves a new use for the schizophrenia drug, Clozaril: to reduce
the risk of recurrent suicidal behavior in patients with schizophrenia
or schizoaffective disorder. FDA
Talk Paper.
FDA approves Zyvox (linezolid) for the treatment of pediatric patients
with nosocomial pneumonia, community-acquired pneumonia, complicated and
uncomplicated skin and skin structure infections, and vancomycin-resistant
Enterococcus faecium infections.
December 9, 2002
- FDA strengthens controls, issues consumer alert on importing certain
prescription drugs. Press
Release.
November 27, 2002
- FDA approves over-the-counter use of Claritin (loratadine) Tablets,
Syrup, and RediTabs for the temporary relief of symptoms of hay fever or
other upper respiratory allergies.
November 26, 2002
- FDA approves Strattera (atomoxetine), the first new drug in three
decades for treatment of symptoms of attention deficit hyperactivity
disorder, or ADHD, which includes inattention, hyperactivity and
impulsiveness. Strattera Label.
- FDA approves teriparatide for the treatment of osteoporosis in
postmenopausal women who are at high risk for having a fracture. The
drug is also approved to increase bone mass in men with primary or
hypogonadal osteoporosis who are at high risk for fracture. FDA
Talk Paper.
November 22, 2002
- FDA approves Alinia (nitazoxanide) for Oral Suspension, a new
prescription drug for the treatment of diarrhea caused by
Cryptosporidium parvum and Giardia lamblia.
November 20, 2002
- CDER announces a joint workshop with Drug Information Association in
collaboration with the North American Society of Pacing and
Electrophysiology on QT prolongation, January 13-14, 2003. Meeting Information
November 19, 2002
- Pfizer issues an important drug warning letter announcing that they
have added new information to the Contraindications and Precautions
sections of the Zoloft (sertraline hydrochloride) labeling. MedWatch
Safety Information
November 15, 2002
- November 15. FDA and Pharmacia advise health care professionals
about new warnings and information in the product labeling of the drug
Bextra (valdecoxib), a drug approved for treatment of osteoarthritis,
rheumatoid arthritis and dysmenorrhea (menstrual pain). FDA
Talk Paper
November 1, 2002
- FDA and Roche have revised several sections of the safety labeling
for Accutane (isotretinoin). MedWatch Safety Information
- FDA approves generic omeprazole delayed-release capsules to compete
with Prilosec for the treatment of certain gastrointestinal conditions. FDA News
October 31, 2002
- October 31. FDA approves over-the-counter marketing of Commit
(nicotine polacrilex lozenge), for adults 18 years of age and older, to
reduce withdrawal symptoms, including nicotine craving, associated with
quitting smoking.
October 28, 2002
- FDA has tentatively approved nefazodone hydrochloride tablets, a
generic version of serzone tablets, for treatment of depression.
October 8, 2002
- Subutex (buprenorphine hydrochloride) and Suboxone tablets (buprenorphine
hydrochloride and naloxone hydrochloride) is approved for the treatment
of opiate dependence. More Information
October 7, 2002
October 4, 2002
- FDA and Roche strengthen the contraindications, warnings,
precautions, and adverse reactions sections of the Lariam (mefloquine
hydrochloride) label. Lariam is used for the treatment of mild to
moderate acute malaria, and to prevent malaria infections.
FDA Safety Information
September 6, 2002
- FDA announces the consolidation of FDA's
responsibility for reviewing new pharmaceutical products into its Center
for Drug Evaluation and Research (CDER). FDA
Press Release.
August 21, 2002
August 13, 2002
August 12, 2002
- FDA approves Eloxatin (oxaliplatin) for use in
patients with advanced colorectal cancer. Information Page with
"Questions and Answers."
July 24, 2002
- FDA approves Zelnorm tablets (tegaserod maleate).
This drug is the first to receive FDA-approval for short-term treatment
of women with irritable bowel syndrome (IBS) whose primary bowel symptom
is constipation. FDA
Talk Paper.
July 17, 2002
- FDA approves Xyrem under a restricted
distribution plan for the treatment of cataplexy associated with
narcolepsy. Information
Page with "Questions and Answers" and "Medication Guide."
(7/17/2002)
July 16, 2002
- July 16. FDA and Elan Pharmaceuticals added a bolded Warning to the
label of Zonegran (zonisamide) to inform healthcare professionals that
pediatric patients appear to be at an increased risk for zonisamide-associated
oligohidrosis and hyperthermia. MedWatch
Safety Information.
July 2, 2002
-
The Boxed Warning, Warnings, and Precautions sections of
Camptosar (irinotecan hydrochloride) label have been revised to identify
patients at higher risk of severe toxicity, to clarify dose modification
guidelines, and to augment information about management of
treatment-related toxicities, including severe and occasionally
life-threatening diarrhea. MedWatch Safety Information.
-
FDA issues a response to a Citizen's Petition submitted
to the agency regarding the regulation of a product called "Nicotine
Water." FDA has determined that this product should be regarded as an
unapproved new drug and cannot be legally marketed as a dietary
supplement. FDA News.
June 27, 2002
June 18, 2002
June 14, 2002
-
AstraZeneca received reports of
medication errors involving confusion between its atypical antipsychotic
Seroquel (quetiapine fumarate), indicated for the treatment of
schizophrenia, and Serzone (nefazodone hydrochloride), a product of
Bristol-Myers Squibb, indicated for the treatment of depression. MedWatch Safety Information.
News Items 2008
News Items 2007
News Items 2006
News Items 2005
News Items 2004
News Items 2003
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Date created: March 3, 2003; Last updated: January, 2008 |
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