FDA Makes New Generic HIV Drug Available Under PEPFAR

The U.S. FDA announced it has granted tentative approval to generic abacavir sulfate tablets, 300 mg, manufactured by Matrix Laboratories, under the expedited review provisions developed for the President's Emergency Plan for AIDS Relief (PEPFAR).

The drug is a generic version of the HIV drug Ziagen, manufactured by GlaxoSmithKline. Tentative approval means that, although existing patents and pediatric exclusivity protection prohibit the marketing of generic Ziagen in the U.S., the drug has been shown to meet all of the FDA's safety, efficacy and manufacturing quality standards, thus qualifying it for purchase under the PEPFAR program.

PEPFAR focuses primarily on supplying HIV treatment and care in 15 countries, the majority of which are in Africa.

Abacavir sulfate is a member of the class of drugs known as nucleoside reverse transcriptase inhibitors, which help keep HIV from reproducing. This antiretroviral drug is intended for use in combination with other antiretroviral agents for the treatment of HIV-1 infection.