Strides Arcolab Ltd has announced that it has received tentative approval from the US Food and Drug (FDA), Administration for Nevirapine tablets 200mg. This is the company's first ANDA approval. This application was reviewed under the expedited review provisions of the President's Emergency Plan for Aids Relief (PEPFAR) programme., a company release stated.
Arun Kumar, vice chairman and CEO, of the company said, "We are pleased to receive this first ANDA tentative approval from US FDA for Nevirapine tablets. This approval represents significant opportunity for the company to commercialise Nevirapine a key anti-retro viral in the treatment of AIDS".
Nevirapine is in the class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), which helps keep the AIDS virus from reproducing. This ARV drug is used in combination with other ARV agents for the treatment of HIV-1 infection.
The company has 4 applications under review with the US FDA under the same programme and another 4 in the pipeline for submission. The company already has 5 WHO pre-qualified ARVs that supplied to more than 37 countries in Africa and Asia.
The company is also partnering with the Clinton Foundation to ensure availability of affordable quality generic ARVs in least developed countries.