Strides Arcolab gets tentative USFDA nod for AIDS drug

Strides Arcolab has announced that the United States Food and Drug Administration (USFDA) has granted tentative approval to the company for one new drug application (NDA) for fixed dose combination of Lamivudine and Stavudine Tablets 150 mg/ 30 mg under the expedited review provisions of the President’s Emergency Plant for AIDS Relief (PEPFAR).

Following this, the total NDAs / ANDAs approvals received under the PEPFAR program has moved up to 11.