Aurobindo gets USFDA nod for oral solution for AIDS drug

Posted AtThe Hindu Businessline

Aurobindo Pharma Ltd on Monday said that it had received tentative approval from the US Food and Drug Administration for its oral solution of the HIV/AIDS drug Lamivudine. The tentative approval is for 10 mg/ml of oral solution of Lamivudine, the company said in a statement.

It said Lamivudine oral solution of 10 mg/ml is the first generic version approval of Epivir oral solution of GlaxosmithKline.

Lamivudine is an antiviral drug called a nucleoside reverse transcriptase inhibitor or NRTI, which is used to treat human immunodeficiency virus (HIV) used in combination with other medicines. It is also used to treat infections due to hepatitis B.

This approval by US FDA once again makes the company to qualify under the President's emergency plan for AIDS relief (PEPFAR) program, it said. Apart from this approval, Aurobindo already has seven product approvals under PEPFAR programme. - PTI

November 07, 2005