TWO NEW GENERIC HIV DRUGS AVAILABLE FOR USE UNDER PEPFAR

The U.S. FDA has granted tentative approval to two generic antiretroviral drugs made by Strides Acrolab under the expedited review provisions created for the President's Emergency Plan for AIDS Relief (PEPFAR).

Tentative approval means existing patent protections currently prohibit the marketing of the product in the U.S., but the product can be purchased under the PEPFAR program.

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

The first new generic product is a fixed-dose combination of stavudine/lamivudine 40-mg/150-mg tablets for use in combination with other antiretroviral drugs for treating HIV-1.

The second is a fixed-dose combination of stavudine/lamivudine (40 mg/150 mg) tablets co-packaged with nevirapine tablets (200 mg) for the treatment of HIV-1.

Earlier this month Strides Arcolab announced it was granted tentative approval for its drug regimen consisting of lamivudine/zidovudine 150-mg/300-mg tablets co-packaged with nevirapine 200-mg tablets.

Drug combinations such as these can significantly decrease the burden on patients, resulting in improved treatment compliance, according to the FDA.