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Mylan Receives FDA Approval for Generic Version of Migraine Treatment Imitrex(R)

By Pharmaceutical Processing | August 10, 2009

Mylan Inc. has announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the 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 word. 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 . 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.

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