FDA approves Mylan's ANDA for generic Solodyn ER tablets for acne treatment

Jul 23 2010

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Matrix Laboratories Limited received final approval on July 20 from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Minocycline Hydrochloride Extended Release Tablets (Minocycline ER), 45 mg, 90 mg and 135 mg, the generic version of Solodyn® ER, a treatment for acne, sold by Medicis Pharmaceuticals Corporation (Medicis). Mylan Pharmaceuticals Inc. commenced immediate shipment of the product after approval.  

Mylan also announced that it reached settlement and license agreements with Medicis resolving patent litigation relating to Minocycline ER, and the company has ceased additional distribution. Pursuant to the terms of the agreements, Medicis will release Mylan from any liability related to the prior sales of this product, and Mylan will have the right to market Minocycline ER in the U.S. beginning in November 2011 or earlier under certain circumstances. Additional terms of the agreement were not disclosed.

Minocycline ER had U.S. sales of approximately $496 million for the 12 months ending March 31, 2010, according to IMS Health. Currently, Mylan has 131 ANDAs pending FDA approval representing $92.1 billion in annual brand sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $21.4 billion in annual brand sales, for the 12 months ending Dec. 31, 2009, according to IMS Health.