Strides Arcolab Ltd has received tentative approvals from the United States Food and Drug Administration (FDA) for two new drug applications (NDA) for fixed dose combination of Lamivudine and Stavudine 150 mg/40 mg tablets.
Lamivudine and Stavudine 150/40mg tablets co-packaged with Nevirapine 200 mg tablets under the expedited review provisions of the President's Emergency Plan for Aids Relief (PEPFAR) program. This takes the total NDAs ANDAs approvals received to 8 under the PEPFAR programme.
Arun Kumar, vice chairman and managing director, of the company said, "the two new NDA approvals being key products in the treatment of HIV will provide a fillip to our aids, TB and malaria (ATM) initiative".
The company also partners the Clinton Foundation to ensure availability of affordable quality generic ARVs in least developed countries.