Aurobindo oral solution gets FDA nod

Aurobindo Pharma Limited has informed that the US FDA has granted tentative approval for the company's Stavudine Oral Solution 1 mg/ml.

This product will now be available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR). Following this approval, the total number of the company's anti-retoviral (ARV) products for PEPFAR programme has gone up to nine.

The company has added that Stavudine Oral Solution 1 mg/ml is the first generic version approval of Zerit for Oral Solution manufactured by Bristol-Myers Squibb.

The product is indicated for use in paediatric patients with HIV, from birth through adolescence.

Stavudine is active against HIV that causes AIDS. It comes in the class of drugs called nucleoside reverse transciptase inhibitors, which help keep the AIDS virus from reproducing.