FDA has told two drug companies to stop marketing sublingual nitroglycerin tablets that have not been approved as safe and effective by the FDA. Glenmark Generics and Konec Inc., have been selling unapproved nitroglycerin in 0.3, 0.4, and 0.6 mg dosages. FDA has seen significant problems with the quality and efficacy of nitroglycerin tablets that are not approved.
Although Glenmark Generics and Konec must stop shipping these drugs by September 2010, there should not be a supply problem. Pfizer's Nitrostat tablets, which are FDA-approved, come in the same dosages....................& more
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