Pharmaceutical Business review

Aurobindo wins FDA approval for stavudine capsules and oral solution

Stavudine capsules 15mg, 20mg, 30mg and 40mg and Stavudine for oral solution 1mg/ml are the generic equivalent of Bristol-Myers Squibb Company’s Zerit 15mg, 20mg, 30mg and 40mg and Zerit for oral solution 1mg/ml respectively.

These drugs fall under the anti-retroviral segment and are indicated for treatment of HIV-1 infection in combination with other antiretroviral agents. Aurobindo now has 63 final and 24 tentative abbreviated new drug application approvals from the FDA.