New Generic HIV Drug Approved for Use Under PEPFAR

The U.S. FDA has granted tentative approval to a generic formulation of the HIV drug efavirenz manufactured by Strides Acrolab under the expedited-review provisions created for the President's Emergency Plan for AIDS Relief (PEPFAR).

The product is the generic equivalent to Bristol-Myers Squibb's Sustiva 600-mg tablets, which is currently subject to patent protection.

FDA tentative approval means that, although existing patents prohibit the marketing of this product 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.

Efavirenz is a non-nucleoside reverse transcriptase inhibitor indicated for use in combination with other medicines to treat HIV.