Mylan Receives FDA Approval For Generic Version Of Migraine Treatment Imitrex(R)

Main Category: Headache / Migraine
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 11 Aug 2009 - 0:00 PDT

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Mylan Inc. (Nasdaq: MYL) announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Sumatriptan Succinate Tablets, 25 mg (base), 50 mg (base) and 100 mg (base). This product is manufactured in Mylan's Morgantown, W.Va. facility.

Mylan Chairman and CEO Robert J. Coury said: "This particular approval is especially important at this time on top of the many other approvals supporting our Morgantown facility and its exemplary 48-year track record of delivering high quality products to our customers and patients from one of the largest pharmaceutical manufacturing plants in the world. I would like to again thank all of Mylan's hardworking employees for their continued dedication to product quality and safety."

Mylan's Sumatriptan Succinate Tablets are the generic version of GlaxoSmithKline's migraine treatment Imitrex(R). This product had total U.S. sales of approximately $934 million for the 12 months ending June 30 for the same strengths, according to IMS Health. Mylan is shipping immediately.

Currently, Mylan has 120 ANDAs pending FDA approval representing $85.6 billion in annual brand sales, according to IMS Health. Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing $17.3 billion in annual brand sales, according to IMS Health.

Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generics and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest -- and highest quality -- product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's third largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies.

Source: Mylan Inc