FDA GRANTS TENTATIVE OK TO GENERIC HIV DRUG

The 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.

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