WASHINGTON, March 16 (UPI) -- The U.S. Food and Drug Administration Tuesday ordered Glenmark Generics and Konec Inc. to stop marketing unapproved nitroglycerin tablets.
Nitroglycerin tablets are placed under the tongue to relieve chest pain or to stop a heart attack. But the tablets manufactured by the two companies have not been proven safe and effective, the FDA said, and the products' labeling has not been reviewed.
The agency's warning letters require Glenmark, a Mahwah, N.J., company and Konec, located in Tucson, Ariz., to remove the unapproved tablets as part of the FDA's Unapproved Drugs Initiative. The initiative was announced in 2006 to address marketed drugs that had not received FDA approval.
"Doctors and patients should know that not all drugs on the market are backed by an FDA approval," said Deborah Autor, director of the FDA's Office of Compliance. "This lack of approval undermines the FDA's efforts to ensure that safe and effective drug products are available to the American public."
Consumers using the unapproved products should continue taking the medications and consult a healthcare professional for guidance on alternative treatment options, the FDA said.
Glenmark and Konec have 15 days to present a plan for removing the products from the market. They have 90 days from the date of the warning letters to stop manufacturing new products and 180 days to stop further shipments of the unapproved nitroglycerin tablets.
