FDA grants final approval for Mylan's Promethazine HCl Tablets

Sep 9 2011NewsGuard 100/100 Score

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Promethazine Hydrochloride (HCl) Tablets USP, 12.5 mg, 25 mg and 50 mg. Promethazine HCl Tablets are used to relieve the symptoms of certain allergic reactions, such as perennial and seasonal allergic rhinitis.

Promethazine HCl Tablets had U.S. sales of approximately $42 million for the 12 months ending June 30, 2011, according to IMS Health. Mylan is shipping this product immediately.

Currently, Mylan has 161 ANDAs pending FDA approval representing $97.1 billion in annual sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $26.9 billion in annual brand sales, for the 12 months ending June 30, 2011, according to IMS Health.

Source:

Mylan Inc.

Posted in: Medical Condition News | Pharmaceutical News

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