FDA shuts down unapproved Glenmark, Konec drugs

SILVER SPRING, Md. The Food and Drug Administration has ordered two generic drug companies to stop marketing unapproved heart attack drugs as part of its Unapproved Drugs Initiative, the agency announced Tuesday.

The FDA ordered Mahwah, N.J.-based Glenmark Generics and Tucson, Ariz.-based Konec to stop marketing nitroglycerin tablets. The tablets are placed under the tongue to relieve chest pain or stop a heart attack.

The FDA announced the initiative in 2006 to address the issue of companies marketing drugs that entered the market before the agency adopted its current regulatory policies, which has allowed them to be marketed without the agency’s approval.

“Doctors and patients should know that not all drugs on the market are backed by FDA approval,” FDA Office of Compliance director Deborah Autor said. “This lack of approval undermines the FDA’s efforts to ensure that safe and effective drug products are available to the American public.”

The FDA has given the two companies 15 days to respond to the warning, 90 days to stop manufacturing the tablets and 180 days to stop further shipment of them. The initiative allows the companies to win approval for the drugs if they undergo FDA review.

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