FDA TENTATIVELY APPROVES DRUG FOR PEPFAR USE

The FDA has tentatively approved Aurobindo Pharma's generic version of Bristol-Myers Squibb's HIV-1 treatment Zerit (stavudine) capsules. Hyderabad, India-based Aurobindo is the first company to receive tentative approval for a generic version of Zerit. As a result of the tentative approval, the drug will be available for consideration and purchase for use outside of the U.S. under President Bush's Emergency Plan for AIDS Relief (PEPFAR), the FDA said. Stavudine is a member of the nucleoside reverse transcripts inhibitors (NRTIs) drug class, which help inhibit the AIDS virus from reproducing. Stavudine is used in combination with other antiretroviral agents for the treatment of HIV-1 infection.