Aurobindo Pharma Ltd has announced that the US FDA has granted tentative approval for its 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 qualify under the President's Emergency Plan for AIDS Relief (PEPFAR) program.
This product is the first generic version of the approved product, Viramune Oral Suspension, 50 mg /5 ml, manufactured by Boehringer Ingelheim Pharmaceuticals. It is indicated for use in pediatric patients with HIV.
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.