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Indian Pharmaceutical Company Receives Tentative Drug Approval Under PEPFAR

November 1, 2010

Strides Arcolab Limited, a pharmaceutical company headquartered in Bangalore, India, on Friday announced it "has received tentative approval from the United States Food and Drug Administration for one [abbreviated] new drug application (ANDA) for fixed dose combination of Lamivudine and Zidovudine tablets 150 mg/300 mg under the expedited review provisions" of PEPFAR, reports. Strides Arcolab "has so far received 16 PEPFAR approvals," according to the news service (10/29). "The company supplies ARV [antiretroviral] products to global procurement agencies and this approval adds to the overall basket of medicines available," according to a Strides Arcolab press release (.pdf) (10/29).

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