Matrix Laboratories' ANDA for Didanosine Delayed-release Capsules receives FDA approval under PEPFAR

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Didanosine Delayed-release Capsules, 125 mg, 200 mg, 250 mg and 400 mg, the generic version of Bristol Myers Squibb's HIV treatment Videx^® EC. This product, which the company expects to begin marketing in the U.S. during the current quarter, will be sold under the Mylan Pharmaceuticals brand. The product will also be sold outside the U.S. in a number of developing countries.

Didanosine Delayed-release Capsules had U.S. sales of approximately $29 million for the 12 months ending Dec. 31, 2009, according to IMS Health.

Currently, Mylan has 140 ANDAs pending FDA approval representing $98.3 billion in annual brand sales, according to IMS Health. Thirty-eight of these pending ANDAs are potential first-to-file opportunities, representing $19.8 billion in annual brand sales, for the 12 months ending Dec. 31, 2009, according to IMS Health.

SOURCE Mylan Inc.