Mylan has received tentative approval from the USFDA for its NDA for Efavirenz Tablets, 50 mg, 100 mg and 200 mg. The approval was secured by the company's subsidiary Matrix Laboratories Limited under the President's Emergency Plan for AIDS Relief (PEPFAR). These innovative paediatric dosages in tablet form were developed by Matrix for use in treating paediatric HIV/AIDS, the company said. Efavirenz is a non-nucleoside reverse transcriptase inhibitor (nNRTI) that has been found to be effective in many combination regimens for the treatment of HIV infection, both in treatment-naive and in treatment-experienced individuals.
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