Bangalore based drug maker Strides Arcolab has announced that the company has secured a tentative approval from the Food and Drug Administration in the US for a new drug application (NDA) with a combination drug containing Lamivudine and Stavudine.
The approval of the drug which is used for the treatment of AIDS, was expedited under the review provisions of the US President’s Emergency Plant 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 multisource anti–retroviral drugs (ARVs) business segment,” said VS Iyer, CEO, India Operations, Strides Arcolab.
The company supplies ARV products to global procurement agencies. The new approval adds to the overall basket of medicines available, said the company.
Source: Business Standard