Aurobindo Pharma Ltd has received tentative approval from the US FDA for efavirenz capsules, 50 mg, 100 mg and 200 mg. This is the company's 33rd generic approval given by US FDA and 18th in ARV line.
This is first generic alternative to 'Sustiva capsules' of Bristol Myers Squibb Co.
Efavirenz 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. It is used in the combination with other NRTI drugs.