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The U.S. Food and Drug Administration today ordered Glenmark Generics of Mahwah, N.J., and Konec Inc. of Tucson, Ariz., to stop marketing unapproved nitroglycerin tablets. The tablets are placed under the tongue to relieve chest pain or to stop a heart attack and are marketed in 0.3 mg, 0.4 mg, and 0.6 mg dosages.
The FDA does not anticipate a supply problem for these products. Pfizer Inc. markets FDA-approved sublingual nitroglycerin tablets in the same strengths and is able to supply the market with approved products. The FDA also will work with patient organizations and health care professionals to ensure that they are aware that an approved product is available.
The agency’s warning letters require Glenmark and Konec to remove the unapproved tablets as part of the FDA's Unapproved Drugs Initiative1. The initiative was announced in 2006 to address marketed drugs that had not received FDA approval.
For more information please visit: Nitroglycerin
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