Articles
FDA Update: March 22, 2010
March 19, 2010
By Lori Clapper, Web Editor
Don't Market Unapproved Tablets!
The FDA ordered two companies to stop marketing unapproved nitroglycerin tablets, Glenmark Generics (Mahwah, NJ) and Konec Inc. (Tuscon, AZ). According to the FDA, the unapproved tablets have not been proven safe or effective, and labeling has not been reviewed. Warning letters were issued to both companies, requiring them to remove the tablets as part of the FDA's Unapproved Drugs Initiative.
The FDA's action should not result in a shortage of nitroglycerin tablets, since Pfizer also markets FDA-approved nitroglycerin tablets and has the ability to supply the market with enough product.
"Doctors and patients should know that not all drugs on the market are backed by an FDA approval," said Deborah M. Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research (CDER). "This lack of approval undermines the FDA's efforts to ensure that safe and effective drug products are available to the American public."
Glenmark and Konex have 15 days to respond with a plan to remove their tablets from the market.
Cleviprex Recalled
The Medicines Company announced today it would voluntarily recall Cleviprex® (clevidipine butyrate) injectable emulsion because visible particulate matter — primarily stainless steel particles — have been observed in some vials. The company is cooperating with the FDA on the recall.
For complete information on the recall, click here.
Data Standards Council Updates
The FDA Data Standards Council has updated the following resources:
