FDA nod for Stride Arcolabs’ AIDS drug combo
11 Apr 2009
Bangalore-based drug maker Strides Arcolab Ltd announced on Thursday that the company has secured a ''tentative'' approval from the US Food and Drug Administration for a new drug application (NDA) for the treatment of AIDS.
The approval is for a combination drug containing a fixed dose combination of Lamivudine and Stavudine tablets 150 mg/130 mg, the company said. The approval of the drug was expedited under the review provisions of the US president's emergency plan for AIDS relief (PEPFAR).
According to the company, the approval has taken the company's total number of NDAs and abbreviated new drug application (ANDAs) approval under the PEPFAR programme to 11.
"This approval is yet another significant milestone in the front line of approvals for key HIV/AIDS medicines. This, combined with our pipeline of second line drugs will make us a significant player in the quality, affordable multi-source anti-retroviral drugs (ARVs) business segment," said V S Iyer, the company's chief executive officer for India operations.
The company supplies ARV products to global procurement agencies. The new approval adds to the overall basket of medicines available, said the company.