FDA APPROVES GENERIC EPIVIR
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.