NEW GENERIC HIV DRUG AVAILABLE FOR PEPFAR USE

The U.S. FDA announced it has granted tentative approval to generic lamivudine tablets, 150 mg, manufactured by Matrix Laboratories under expedited-review provisions developed for the President's Emergency Plan for AIDS Relief (PEPFAR).

Final approval cannot be granted at this time because the reference product, GlaxoSmithKline's HIV drug Epivir, is subject to patent protection.

But tentative approval means that, although existing patents prohibit the marketing of this product in the U.S., the product 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.

Lamivudine is indicated for use in combination with other antiretroviral agents for the treatment of HIV.