The U.S. Food and Drug Administration ordered two companies yesterday to stop marketing unapproved nitroglycerin tablets, used to relieve chest pain or to stop a heart attack. The companies are Glenmark Generics of Mahwah, N.J., and Konec Inc. of Tuscon, Ariz.
From the FDA’s press release:
The unapproved nitroglycerin tablets have not been proven safe and effective, and the FDA has not reviewed the quality and labeling of these products. The unapproved products may differ from approved nitroglycerin products in some respects, such as formulation and labeling. The FDA has seen significant quality and efficacy problems with some unapproved nitroglycerin products.
“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.”
As part of the FDA’s Unapproved Drug Initiative, the agency has ordered dozens of companies to stop selling drugs that haven’t gone through the proper regulatory process for market approval.
Read the FDA’s list and about its enforcement actions here.
