Aurobindo Pharma Receives Tentative FDA Approval to Produce Oral Formulations of Generic Antiretroviral Stavudine for PEPFAR

FDA on Friday granted tentative approval to Indian drug manufacturer Aurobindo Pharma to produce an oral formulation of the antiretroviral drug stavudine, the Press Trust of India reports (Press Trust of India, 6/29). Stavudine is a generic form of Bristol-Myers Squibb's Zerit (Aurobindo release, 6/30). The tentative approval allows Aurobindo to produce 15mg, 20mg, 30mg and 40mg oral capsules of the drug (Press Trust of India, 6/29). The Indian drug manufacturer received tentative FDA approval in December 2005 to produce stavudine for pediatric use (Kaiser Daily HIV/AIDS Report, 12/22/05). The tentative approval designation means the generic drug meets FDA safety and efficacy standards but cannot be sold in the U.S. because of existing patents or exclusivity agreements, although it can be used by relief organizations outside the U.S. under the President's Emergency Plan for AIDS Relief (Kaiser Daily HIV/AIDS Report, 6/29).

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