STRIDES ARCOLAB RECEIVES TENTATIVE APPROVAL FOR GENERIC ARV

Strides Arcolab has received tentative approval from the FDA for stavudine capsules 30 mg and 40 mg. This would be the company's second abbreviated new drug application approval. This application was reviewed under the expedited review provisions of the President's Emergency Plan for Aids Relief (PEPFAR).

Stavudine is in the class of drugs called nucleoside analog reverse transcriptase inhibitors, which help prevent HIV from reproducing. This antiretroviral (ARV) drug is used in combination with other ARV agents for the treatment of HIV-1 infection.

The company has three applications under review by the FDA and another four products in the pipeline under PEPFAR. The company also has six World Health Organization pre-qualified ARVs, which are supplied in 37 countries in Africa and Asia.

The company is also partnering with the Clinton Foundation to increase the availability of affordable ARVs in the least developed countries.