AEGiS-FDA: Tentative approval of lamivudine oral solution

Important note: Information in this article was accurate in 2006. The state of the art may have changed since the publication date.

Tentative approval of lamivudine oral solution

Food and Drug Administration - June 22, 2006
Richard Klein

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).

Richard Klein, HIV/AIDS Program Director

Office of Special Health Issues

Food and Drug Administration
060622
FD060602

SOURCE: Food and Drug Administration (FDA).

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