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www.fdanews.com/articles/89337-strides-arcolab-s-arv-combination-nears-approval

STRIDES ARCOLAB'S ARV COMBINATION NEARS APPROVAL

March 5, 2007

Strides Arcolab has received tentative approval from the FDA for its HIV drug regimen consisting of lamivudine/zidovudine 150-mg/300-mg tablets co-packaged with nevirapine 200-mg tablets, the company announced. 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. "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.