Aurobindo drug gets US FDA nod

Aurobindo Pharma Limited has received a tentative approval from the US FDA for the company's Nevirapine Oral Suspension 50 mg/5 ml.

This product approval by US FDA adds to the company's product basket for the regulated market and also qualifies under the President's Emergency Plan for AIDS Relief (PEPFAR) programme.

This product is the first generic version of the approved product, Viramune Oral Suspension 50 mg/5ml, manufactured by Boehringer Ingelheim Pharmaceuticals.

Nevirapine is active against the human immunodeficiency virus (HIV) that causes AIDS. It is in the class of drugs called nonnucleoside reverse transcriptase inhibitors (NNRTIs), which helps keep the AIDS virus from reproducing.

It is used in combination with other antiretroviral agents for the treatment of HIV-1 infection, according to a company press release here on Tuesday.