MYL<>FDA tentatively approves Mylan's HIV combo
The FDA grants tentative approval for Mylan's (NASDAQ:MYL) emtricitabine and tenofovir disoproxil fumarate combination tablets (200 mg/300 mg) co-packaged with nevirapine tablets (200 mg) for the treatment of patients with HIV-1. The product is cleared for use alone or in combination with other antiretrovirals for the treatment of HIV-1 infection in adults and pediatric patients at least 12 years old and weighing at least 38 kg.
Tentative approval means that the product meets the quality, safety and efficacy standards for regulatory clearance, but is not eligible for marketing in the U.S. due to patent protections, although it clears the product for sale ex. U.S. under the PEPFAR program (President's Emergency Plan for AIDS Relief).
The branded Emtricitabine/tenofovir (200 mg/300 mg) product is Gilead Sciences' (NASDAQ:GILD) Truvada. Nevirapine (200 mg) tablets are sold under the brand name Viramune by Boehringer Ingelheim.
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