Strides gets US nod for AIDS drug

Bangalore-based Strides Arcolab has received a tentative approval from the United States Food and Drug Administration for Nevirapine tablets 200mg.

Announcing this, Arun Kumar "� vice chairman and CEO of the company said, this is the company's first ANDA (abbreviated new drug application) approval. The application was reviewed under the expedited review provisions of the President's Emergency Plan for Aids Relief (PEPFAR) programme.

He further said, "We are pleased to receive this first ANDA tentative approval from USFDA for Nevirapine tablets. The approval represents significant opportunity for the company to commercialise Nevirapine - a key anti-retro viral (ARVs) 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 treating HIV-1 infection.

The company has four applications under review with the USFDA under the same programme and another four in the pipeline for submission. The company has five World Health Organisation (WHO) pre-qualified ARVs which are supplied to over 37 countries in Africa and Asia.

The company has partnered the Clinton Foundation to ensure the availability of affordable quality generic ARVs in least developed countries, said Arun Kumar.