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Mylan Wins FDA Nod For Generic Actigall

March 3, 2010 (FinancialWire) — Mylan Inc. (NASDAQ: MYL) said that its Mylan Pharmaceuticals Inc. unit has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Ursodiol Capsules USP, 300 mg, the generic version of Watson’s gastrointestinal agent Actigall Capsules.

Ursodiol Capsules had U.S. sales of around $30 million for the 12 months ending Dec. 31, 2009 according to IMS Health. Mylan said its version is available for immediate shipment.

Currently, Mylan has 142 ANDAs pending U.S. Food and Drug Administration approval representing $87.5 billion in annual brand sales, according to IMS Health.

Pennsylvania-based Mylan is a generic and specialty pharmaceutical firm that provides products to customers in more than 140 countries and territories.

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