NEW ARV COMBINATION FOR USE UNDER PEPFAR NEARS APPROVAL

Strides Arcolab has received tentative approval from the U.S. FDA for its HIV drug regimen consisting of lamivudine/zidovudine 150-mg/300-mg tablets co-packaged with nevirapine 200-mg tablets. The drug would be approved for use under the President's Emergency Plan for Aids Relief (PEPFAR) program.

PEPFAR aims to prevent and treat HIV -- which includes supplying antiretroviral (ARV) drugs -- in countries where the disease is most prevalent. Fourteen of the program's focus countries are in Africa. Last month the FDA issued a guidance exempting companies submitting drug applications for use under PEPFAR from paying user fees.

"We are pleased to receive our first tentative approval for a [new drug application] from the FDA," Arun Kumar, vice chairman and managing director, said. "This approval represents a significant opportunity for Strides to commercialize field adaptable fixed dose combination ARVs co-packaged with other ARVs for ease of patient compliance."

The company has also received tentative approval from the FDA for generic stavudine capsules and nevirapine tablets. The FDA is reviewing another four of the company's applications under PEPFAR, and 12 others are in the pipeline. The company has six ARVs that have received World Health Organization prequalification and that are supplied in many African countries.

The company also said it is partnering with the Clinton Foundation to make affordable ARVs available in the least developed countries.