The Hindu Business Line : Strides AIDS drug gets USFDA nod

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Bangalore March 5 Strides Arcolab said it has got its first, but tentative USFDA approval for an NDA (new drug application) for a combination anti-AIDS drug.

The US regulator has approved Lamivudine/Zidovudine 150 mg/300 mg tablets co-packaged with Nevirapine 200 mg tablets. The application was reviewed under the expedited review provisions of the US PEPFAR (President's Emergency Plan for Aids Relief programme,) an official release said.

Mr Arun Kumar, Vice-Chairman and MD, Strides Arcolab, said: "This approval represents a significant opportunity for Strides to commercialise field adaptable fixed dose combination ARVs (anti-retroviral) co-packaged with other ARVs for ease of patient compliance."

The company has already received tentative approval from the FDA for Stavudine capsules and Nevirapine tablets. Four applications are under review under the same programme and another 12 are in the pipeline for development and submission. The company has six WHO pre-qualified ARVs that are supplied to more than 37 countries in Africa and Asia.

The company said it was partnering with the Clinton Foundation to ensure availability of affordable generic ARVs in poorer countries.

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