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Aurobindo Pharma gets USFDA nod for Zidovudine tablets

Posted on: July 25, 2009 at 2:22 pm | 55 views




Aurobindo Pharma gets USFDA nod for Zidovudine tablets

Aurobindo Pharma 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 & Drug Administration (USFDA).

Both these 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).

Aurobindo now 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).

Shares of the company declined Rs 2.9, or 0.53%, to trade at Rs 543. The total volume of shares traded was 51,097 at the BSE (3.05 p.m., Friday).

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