Hyderabad headquartered Aurobindo Pharma Limited has informed that it has secured 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 & Drug Administration (USFDA).
The company stated in an official communiqué that both these new drug applications are for periodic 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-retroviral (ARVs).
At present, Aurobindo has a total of 98 ANDA approvals (70 final approvals and 28 Tentative approvals) from USFDA, which include 30 products in the ARV segment (8 Final approvals and 22 Tentative approvals).
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