US FDA grants tentative approval to Aurobindo''s anti-AIDS drug for children

The US FDA has granted its tentative approval to Aurobindo Pharma Ltd''s Stavudine Oral solution 1mg / ml.

The product will now be available under the ''US President''s emergency plan for AIDS relief'' (PEPFAR). Following this approval, the total number of Aurobindo Pharma ARV products for the PEPFAR programme has gone up to nine.

Stavudine Oral solution 1mg / ml is the first generic version approval of Zerit for oral solutions manufactured by Bristol-Myers Squibb. This child-friendly product is indicated for use in paediatric patients with HIV, from birth through adolescence.

Stavudine is active against the human immunodeficiency virus (HIV) that causes AIDS. It is in the class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs), which help keep the AIDS virus from reproducing. This anti-retroviral drug is used in combination with other anti-retroviral agents for the treatment of HIV-1 infection.