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The Food and Drug Administration (FDA) today (November4, 2005) announced the tentative approval of Lamivudine Oral Solution, 10 mg/mL manufactured by Aurobindo Pharma LTD. of Hyderabad , India.  Lamivudine Oral Solution is the first generic version of the already approved Epivir Oral Solution, 10 mg/mL, manufactured by GlaxoSmithKline. This child-friendly-product is indicated for use in pediatric patients with HIV from three months to 16 years.

Lamivudine is in the class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs), which help keep the AIDS virus from reproducing. This antiretroviral drug is intended to be used in combination with other antiretroviral agents for the treatment of HIV-1 infection.

FDA's tentative approval of this product means that although existing patents and/or exclusivity prevent marketing of this product in the United States, the product meet all of FDA's safety, efficacy, and manufacturing quality standards required for marketing in the U.S. and it will now be available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).


Richard Klein
HIV/AIDS Program Director
Office of Special Health Issues
Food and Drug Administration

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