Strides Arcolab Ltd has received tentative approval from the US Food and Drug Administration for Lamivudine/Zidovudine 150 mg/300 mg tablets co-packaged with Nevirapine 200 mg tablets.

This is the company's first NDA 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 managing director of the company said, "We are pleased to receive our first tentative approval for a NDA from the US FDA. This approval represents a significant opportunity for Strides to commercialise field adaptable fixed dose combination ARVs co-packaged with other ARVs for ease of patient compliance.

The company has already received tentative approval from FDA for Stavudine capsules and Nevirapine tablets. Four applications are under review with the US FDA under the same programme and another 12 are in the pipeline for development and submission. The company 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.