Mylan's Matrix Receives Tentative FDA Approval Under PEPFAR for Lamivudine and Zidovudine Tablets

Mylan Inc. MYL today announced that its subsidiary 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 for Lamivudine and Zidovudine Tablets, 30 mg/60 mg. The NDA is based on the reference listed drug Combivir, by ViiV Healthcare. This innovative pediatric fixed-dose combination in tablet form was developed by Matrix for use in treating children with HIV/AIDS. This product will be eligible for purchase outside the U.S. in certain developing countries.