Mylan Receives Tentative FDA Approval Through PEPFAR for Pediatric HIV/AIDS Therapy

Mylan Inc.

today announced that its subsidiary Mylan Laboratories Limited (formerly Matrix Laboratories Limited) has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief for its New Drug Application (NDA) for Abacavir Sulfate and Lamivudine Tablets, 60 mg/30 mg. This fixed-dose combination product was developed for use in treating children with HIV/AIDS and is based on the adult-strength, brand version of the product EPZICOM®, by Viiv Healthcare. Mylan received tentative PEPFAR approval for its adult-strength, generic version of EPZICOM on Mar. 30, 2009.