Tentative approval of generic lamivudine oral solution
The Food and Drug Administration (FDA) granted tentative approval on June 22, 2006 for generic lamivudine - oral solution, 10 mg/mL manufactured by Cipla Limited, Mumbai, India. This action represents the second tentative approval of a generic version of the already FDA 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.
Tentative approval for a generic lamivudine oral solution was first granted on November 4, 2005 to a formulation produced by another manufacturer in India.
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 meets 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).
HIV/AIDS Program Director
Office of Special Health Issues
Food and Drug Administration