Strides received US FDA approval for Lamivudine and Stavudine

Strides Arcolab Limited (Strides) announced that it has received tentative approval from the United States ? Food and Drug Administration 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 Plan for AIDS Relief (PEPFAR).

V S Iyer, Chief Executive Officer ? India Operations of Strides stated:

“This approval is yet another significant milestone in the front line of approvals for key HIV / AIDS medicines. This takes the total NDAs / ANDAs approvals received to 11 under the PEPFAR program. This, combined with our pipeline of second line drugs will make us a significant player in the quality, affordable multi- source ARVs business segment.”

The company supplies ARV products to global procurement agencies and this approval adds to the overall basket of medicines available.

Source: Strides Arcolab Limited, India

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