STRIDES ACROLAB WINS TENTATIVE APPROVAL FOR TWO COMBINATION DRUGS

The FDA has granted tentative approval to two generic combination HIV treatments 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 generic products in the U.S., but the drugs can be purchased under the PEPFAR program, which supplies HIV drugs to the developing world.

The first 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.

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