FDA approves Mylan Pharmaceuticals' ANDA for Ursodiol Capsules

Mar 3 2010

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ursodiol Capsules USP, 300 mg, the generic version of Watson's gastrointestinal agent Actigall® Capsules.

Ursodiol Capsules had U.S. sales of approximately $30 million for the 12 months ending Dec. 31, 2009 according to IMS Health. Mylan's 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. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $19.6 billion in annual brand sales, for the 12 months ending June 30, 2009, according to IMS Health.