Aurobindo Pharma Ltd has received approval from the US FDA for Efavirenz tablets, 600 mg. This is first generic approval given by US FDA to the Company ahead of the rest of pharmaceutical industry, the company claims in a release.
Efavirenz is a key ARV in the Anti aids therapy. This is the third ARV approval, the other products being, Nevirapine and Lamivudine. Efavirenz represents a significant opportunity in Africas for the Company under PEPFAR programme.
Efavirenz is internationally called as Sustiva, manufactured by Bristol Myers Squibb Co. Efavirenz is in the class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), which helps keep the AIDS virus from reproducing in cells.
The drug will now be available for consideration for purchase under the Presidents Emergency Plan for AIDS Relief (PEPFAR), a five-year program being run to fight HIV/AIDS pandemic, the release added.