Company Watch

Aurobindo gets tentative US FDA approval for AIDS drug

Our News Bureau - Mumbai

Aurobindo Pharma has received tentative United States Food and Drug Administration (US FDA) approval for its New Drug Application (NDA) abacavir sulfate 60mg tablets. It is a NDA 22-293, which provides for the use of abacavir in combination with other anti-retrovirals for use in paediatric patients for the treatment of HIV-1infection.

It is company's 77th ANDA approval from US FDA. The company had earlier obtained tentative approvals for abacavir sulfate tablets 300mg and abacavir sulfate oral solution 20mg/mL. Aurobindo has also received tentative US FDA approval for abacavir sulfate/lamivudine tablets 600mg/300mg to manufacture and market in the US. Abacavir sulfate/lamivudine tablets 600mg/300mg are the generic equivalent of Epzicom tablets 600mg/300mg of SmithKline Beecham Corporation and falls under the anti-retroviral (ARV) segment. This product has been reviewed under the President's Emergency Plan for AIDS Relief (PEPFAR).