Date:22/06/2005 URL: http://www.thehindubusinessline.com/2005/06/22/stories/2005062202210200.htm

Back Aurobindo Pharma gets USFDA nod for another ARV

Our Bureau

Hyderabad , June 21

AUROBINDO Pharma Ltd (APL) has announced that it has crossed one more milestone in the arena of anti-retrovirals (ARVs) with the United States Food and Drugs Administration granting tentative approval for the company's ARV drug - Nevirapine.

Nevirapine is a key ARV in the treatment of AIDS. It is in the class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), which helps keep the AIDS virus from reproducing.

This antiretroviral drug is used in combination with other antiretroviral agents for the treatment of HIV-1 infection. This is the second approval received from the USFDA under PEPFAR (President's Emergency Plan for AIDS Relief) programme. Earlier, the company received approval for Lamivudine.

APL said it is one among very few most vertically integrated companies to participate in PEPFAR programme. An amount of $15-billion was earmarked for the five-year PEPFAR programme, including around $1-billion per year for medicines.

According to the company, approvals for product, plant and bioequivalence by USFDA were important qualifying criteria to participate in the programme. The company believes that this is another significant landmark in penetrating the global ARVs business. In the near term, the company expects to file a few other relevant ARV filings.