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news.Mylan, a US-based generic pharmaceutical company, has announced that Matrix Laboratories, its India-based subsidiary in which it holds a 71.2% controlling interest, has received the first tentative approval from the FDA under the President's Emergency Plan for AIDS Relief for its abbreviated new drug application for emtricitabine and tenofovir disoproxil fumarate tablets, 200mg/300mg.
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Emtricitabine and tenofovir disoproxil fumarate tablets are the generic version of Gilead Sciences’s Truvada tablets.
Truvada is a second-line anti-HIV drug in the nucleoside reverse transcriptase inhibitor family and is used in combination with other medications to control HIV infection.
Robert Coury, vice chairman and CEO of Mylan, said: “This product approval is yet another important step in providing access to a range of critical HIV medications to patients in developing countries. Mylan and Matrix continue to make a significant contribution to bringing down the cost of these vital treatments through the expansion of our high-quality anti-retroviral franchise.”