Amendment: Corrects the name of the drug and activity in headlineMylan Inc. (MYL) said Thursday its subsidiary Mylan Pharmaceuticals Inc. has received approval from the US Food and Drug Administration for its Abbreviated New Drug Application, or ANDA, for Topiramate Capsules indicated for the treatment of convulsions and migraine headaches in adults.
The Canonsburg, Pennsylvania-based specialty pharma's Topiramate Capsules, 15 mg and 20mg, are the generic version of Ortho McNeil's anticonvulsant Topamax Sprinkle Capsules, 15 mg and 25 mg.
Topiramate Capsules had total U.S. sales of nearly $58 million for the 12 months ending June 30, 2009 for the same strengths, according to IMS Health. Mylan has already launched the product.
Mylan currently has 121 ANDAs pending FDA approval representing $85.7 billion in annual brand sales, according to IMS Health. Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing $17.9 billion in annual brand sales.
In pre-market trading, the stock of Mylan is trading at $16.77, higher by $0.40 or 2.44%.
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