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FDA halts marketing of unapproved nitroglycerin tablets
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The FDA issued warning letters yesterday to two companies, Glenmark Generics of Mahwah, N.J. and Konec Inc. of Tucson, Ariz., warning them to cease distribution of unapproved sublingual nitroglycerin tablets.
The medication, which is used to relieve chest pain or to stop MI, is being marketed by the companies in 0.3-mg, 0.4-mg and 0.6-mg dosages, according to an FDA press release. The FDA warned that the products have not been proven to be safe and effective and may differ from similarly approved nitroglycerin products in formulation and labeling.
These actions are part of the FDA’s Unapproved Drugs Initiative, launched in 2006 to address marketed drugs that have not received FDA approval. “Consumers are entitled to know that their drugs meet FDA standards, and it is a priority for the agency to remove from the market unapproved products that expose consumers to potentially unsafe, ineffective or poor-quality drugs,” Janet Woodcock, MD, director at the FDA’s Center for Drug Evaluation and Research, said in a press release.
Glenmark and Konec must present the FDA with a plan for removing their products from the market within 15 days. The companies must stop manufacturing new products within 90 days of the date the FDA warning letters were issued and 180 days to stop further shipment of existing products.
The FDA encourages consumers using the unapproved products to continue taking their medication and to consult a health care provider for guidance on alternative treatment options. FDA–approved sublingual nitroglycerin tablets are currently available in the same dosage formulations from Pfizer, and the agency did not anticipate supply problems for these products.
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