Highlights
In
the News
• February
21. FDA and Novartis have strengthened the BOXED WARNING and WARNINGS sections
of the prescribing information (PI) for Clozaril (clozapine). MedWatch 2002 Safety Information alert
for Clozaril (clozapine).
• February
19. FDA approves Zevalin, a new therapy that for the first time
includes a monoclonal antibody that is combined with a radioactive
chemical. Zevalin is approved to treat low-grade B-cell non-Hodgkins
Lymphoma.
FDA Talk Paper.
• February
1. FDA approves Gleevec (imatinib mesylate) to treat
gastrointestinal stromal tumor (GIST), a cancer affecting about 5,000
people in the United States FDA
Talk Paper and Label.
• January 31. Best
Pharmaceuticals for Children Act is signed January 4, 2002. Text
of the Act. (PDF)
• January 23. FDA
responds to recent requests from the Irritable Bowel Syndrome (IBS)
patient community for information regarding the status of Lotronex (alosetron
HCl) Tablets. Letter
to IBS Patients.
• January 22. FDA
approves Orfadin (nitisinone) capsules, to treat hereditary
tyrosinemia type I, a rare pediatric disease causing progressive liver
failure and liver cancer in young children. FDA
Talk Paper.
Recently
Added Pages:
• Commonly Asked Questions about CDER
• Drug
Firm Annual Registration Status Query
• Drug Products Application.
What you need to know to submit an application to market a new drug
product.
• Drug Shortages Page.
Identifies medications in short supply.
• Medication Errors.
Covers
drug products associated with medication errors, how to report a medication error, and
related information.
• New Drug
Development in the United States. An educational seminar.
• Oncology Tools contains information on cancer and approved cancer drug therapies.
•
Regulatory
Pharmacology and Toxicology. Covers guidances, reviewer
training and contacts.
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