Mylan Receives Approval for Generic Version of Actigall(R)
PITTSBURGH, March 2 /PRNewswire-FirstCall/ -- 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 ActigallŪ 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.
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information, please visit www.mylan.com.
SOURCE Mylan Inc.