Aurobindo Pharma has received final US FDA approval for Stavudine capsules 15,mg, 20 mg, 30 mg and 40 mg and Stavudine for oral solution 1 mg/ml. The company now has 63 final and 24 tentative ANDA approvals from US FDA.
Stavudine capsules and oral solution are the generic equivalent of Bristol-Myers Squibb Company's Zerit capsules and oral solution. These fall under the anti-retroviral segment and are indicated for treatment of HIV-1 infection in combination with other antiretroviral agents and has a market size of approximately US$ 61 million for the twelve months ending June 2008.