Mylan’s subsidiary Matrix Laboratories Limited announced today that it 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 Efavirenz Tablets, 50 mg, 100 mg and 200 mg.
Mylan President Heather Bresch commented: "This New Drug Application represents another successful innovation by Matrix in the fight against HIV/AIDS. Our HIV/AIDS antiretroviral (ARV) franchise continues to grow and to bring more affordable, high quality medications to patients in the developing world. We are extremely pleased to be able to add these new dosages to the basket of treatment options currently available to the medical community, and to expand our portfolio of products for treating pediatric HIV/AIDS."
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Sign Up for our Free Stock NewsletterMylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies.
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