Aurobindo Receives Approval For Zidovudine, Lamivudine And Zidovudine Tablets

Aurobindo has received the final approval for Zidovudine Tablets 60mg (NDA 22-294) and tentative approval for Lamivudine & Zidovudine Tablets 30mg/60mg(NDA 22-296) from the US Food and Drug Administration (FDA).

Reportedly, both the new drug applications are for pediatric strengths and are developed based on United Nations initiative to develop pediatric formulations. The products are indicated for the treatment of HIV-1 infection in combination with other anti-retrovirals (ARVs).

The company has a total of 98 Abbreviated New Drug Applications (ANDA) approvals from FDA, which include 30 products in the ARV segment.

Aurobindo, headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients.