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Aurobindo wins FDA approval for stavudine capsules and oral solution

Aurobindo Pharma has received final approval from the FDA for two of its tentatively approved abbreviated new drug applications namely stavudine capsules 15mg, 20mg, 30mg and 40mg and stavudine for oral solution 1mg/ml.

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.