Aurobindo Pharma Limited, a Rs 2950 crore plus Hyderabad based pharma major, has received the final approval for Zidovudine tablets 60mg (NDA 22-294) and tentative approval for Lamivudine & Zidovudine 30mg / 60mg (NDA 22-296) from the US Food & Drug Administration (US FDA).
Both these new drug applications are for paediatric strengths and are developed based on United Nations initiative to develop paediatric formulations. The products are indicated for the treatment of HIV-1 infection in combination with other anti-retrovirals (ARVs).
Aurobindo now has a total of 98 ANDA approvals (70 final approvals and 28 tentative approvals) from US FDA, which include 30 products in the ARV segment (8 final approvals and 22 tentative approvals).