Warning Letter to Glenmark for Selling Unapproved Drug

Posted on Mar 22, 2010 in Uncategorized

Submitted by Amit Pathania on Wed, 03/17/2010 – 10:47 Pharmaceutical Sector Featured Health TNM Glenmark

 

On Tuesday, the Food and Drug Administration warned Glenmark Pharmaceuticals Ltd. for selling nitroglycerin tablets without approval.

FDA said, “Based upon our information, there are no FDA-approved applications on file for nitroglycerin tablets in doses of 0.3 milligrams, 0.4 milligrams and 0.6 milligrams”.

However, Glenmark said that nitroglycerin was an old drug that was earlier “grandfathered” with a group of medicines sold in the United States before the Food Drug and Cosmetic Act in 1938.

Since 2006, the FDA has made an attempt to eliminate older unapproved drugs from the market.

Meanwhile, Glenmark said that it is “evaluating the situation and will take appropriate measures”.

The company is hopeful that the sales from nitroglycerin tablets will not have a considerable impact on their FY 2010-11 financial figures.

Glenmark has been given 15 days to answer to the FDA with a plan for getting rid of their products from the market, while three months from the date of the warning letters to cease producing new products and six months days to stop further delivery of existing products.