The Hindu Business Line : Aurobindo drug gets USFDA nod

Aurobindo Pharma Ltd (APL) has announced that the company has received tentative approval from the US Food and Drug Administration (USFDA) for Efavirenz capsules, 50 mg, 100 mg & 200 mg dosages. This is the company's 33rd generic approval given by US FDA and 18th in ARV (Anti Retro Virals) line, targeted at the treatment of HIV/AIDS infection, a press release from the Hyderabad-based, APL said.

Efavirenz is the first generic alternative to Sustiva Capsules of Bristol Myers Squibb Co. It is a key ARV in the Anti AIDS therapy. Efavirenz represents a significant opportunity in Africas for the company under PEPFAR programme. Efavirenz is in the class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), which helps keep the AIDS virus from reproducing in cells.

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