Strides Arcolab Ltd has received tentative approval from the US Food and Drug Administration for Stavudine Capsules USP, 30mg and 40mg. This is the company's second ANDA approval. This application was reviewed under the expedited review provisions of the President's Emergency Plan for Aids Relief [PEPFAR] programme.

Arun Kumar, vice chairman and CEO, the company said, "We are pleased to receive this second ANDA tentative approval from US FDA for Stavudine Capsules. This approval represents significant opportunity for Strides to commercialize Stavudine a key anti-retro viral in the treatment of AIDS."

Stavudine is in the class of drugs called nucleoside analog reverse transcriptase inhibitors, 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 3 applications under review with the US FDA under the same programme and another 4 in the pipeline for submission. The company already has 6 WHO pre-qualified ARVs, which are 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.