STRIDES ARCOLAB GETS TENTATIVE APPROVAL FOR GENERIC ARV

Strides Arcolab has received tentative approval from the FDA for nevirapine, an HIV drug. Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that helps prevent the HIV virus from reproducing. This drug is used in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection. It is the generic version of Boehringer Ingelheim's Viramune.

This application was reviewed under the expedited-review provisions of the President's Emergency Plan for Aids Relief (PEPFAR) program. The company said it has four other applications under review by the FDA under PEPFAR and another four in the pipeline. It has developed five ARVs that have received WHO pre-qualification and that are supplied to 37 countries in Africa and Asia.

The company also partners with the Clinton Foundation to ensure availability of affordable generic ARVs in the least-developed countries.