FDA provides tentative approval under PEPFAR for Matrix's Lamivudine and Zidovudine NDA

Mylan Inc. (Nasdaq: 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 (PEPFAR) for its New Drug Application (NDA) 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 (FDC) 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.

Mylan President Heather Bresch said: "The approval of Lamivudine and Zidovudine is particularly important because it makes available an innovative FDC treatment option for children who are living with HIV/AIDS in developing countries. The addition of this product to our ARV franchise is a critical next step in helping to extend and improve the quality of life of people living with HIV/AIDS and to continue to expand access to high quality, affordable ARVs."

Lamivudine and Zidovudine Tablets, a combination of two nucleoside analogue reverse transcriptase inhibitors, are used in combination with other medications to control HIV infection. The FDA's tentative approval under PEPFAR means that Matrix's product meets all of the agency's manufacturing quality, safety and efficacy standards.

Matrix's wide range of ARV products includes active pharmaceutical ingredients and 34 first- and second-line finished doses, eight of which are pediatric products. The company's emphasis on producing affordable products has allowed it to drive down the average annual cost per patient of effective therapies. Approximately 30% of HIV/AIDS patients in developing countries depend on a Matrix ARV product.