FDA approves
another generic anti-HIV drug for PEPFAR

The U.S. Food and Drug Administration has given tentative approval to Indian generic pharmaceutical firm Aurobinda Pharma to produce a generic version of Bristol-Myers Squibb's anti-HIV drug Zerit. The drug will be available for purchase and distribution through the five-year, $15 billion President's Emergency Plan for AIDS Relief, which aims to combat HIV in 15 developing nations. The drug was approved by the FDA under a fast-track review process for generic drugs that are intended for use in poor countries. "We are pleased to announce another completed drug review by HHS and the Administration in our continuing efforts to make available safe and effective AIDS treatments," said Health and Human Services Secretary Mike Leavitt. The generic version of Zerit will not be available in the United States or other Western nations because of patent protections on the brand-name medication.