Don't sell unapproved Nitroglycerin pills: FDA to Glenmark

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The Food and Drug Administration (FDA) has ordered pharmaceutical major Glenmark Generics to stop marketing unapproved Nitroglycerin tablets, The pills are placed under the tongue to relieve chest pain or to stop a heart attack and come in 0.3 milligram, 0.4 milligram, and 0.6 milligram doses.

However the FDA doesn't see any supply problem for the drug as Pfizer markets FDA-approved sublingual nitroglycerin tablets in the same strengths and, is able to supply the market with approved products.

Glenmark has 15 days to respond to the FDA with a plan for removing their products from the market, 90 days from the date of the warning letters to stop manufacturing new products and 180 days to stop further shipment of existing products.

Nitroglycerin is a very old drug product that has been previously classified as a 'grandfathered' drug in the United States. Grandfathered products are drug products that were manufactured and sold in the United States prior to the passage of the Food Drug and Cosmetic Act in 1938 and there are a number of these products currently marketed in US without being the subject of an FDA-approved New Drug Application (NDA).

In accordance with an FDA policy issued in June of 2006, FDA is transitioning grandfathered products to FDA-approved NDA products. The FDA will periodically initiate action against a group of specific grandfathered products upon FDA approval of an NDA for the grandfathered products.  FDA generally initiates its action against manufacturers of non-FDA approved products by issuing warning letters to the manufacturers.
 
Commenting on the issue, a Glenmark official said, "The company was issued a similar warning letter along with one other company on March 16, 2010.  We are evaluating the situation and will take appropriate measures. We believe that the sales from Nitroglycerin tablets will not have a significant bearing on our FY 2010-11 financial numbers."