FDAnews Drug Daily Bulletin


Nov. 15, 2005

The FDA has tentatively approved Aurobindo Pharma's lamivudine 10 mg/mL, a generic version of GlaxoSmithKline's Epivir Oral Solution, a child-friendly AIDS drug.

Aurobindo's product is indicated for use in pediatric HIV patients from three months to 16 years old, and will be available for purchase under President Bush's Emergency Plan for AIDS Relief (PEPFAR), the FDA said. Aurobindo's product is the first Epivir generic to receive FDA approval for purchase under the PEPFAR program, the agency said.

Lamivudine is a member of the nucleoside reverse transcriptase inhibitor (NRTI) drug class, which helps to keep the AIDS virus from reproducing in cells, and is used with other antiretroviral agents for treatment of HIV-1 infection.