FDAnews Drug Daily Bulletin

AUROBINDO GETS TENTATIVE APPROVAL FOR GENERIC PEDIATRIC AIDS DRUG

July 10, 2006
A A

The FDA has granted tentative approval to the generic version of abacavir sulfate oral solution, an HIV/AIDS medication manufactured by India-based Aurobindo Pharma. The drug is the first generic version of Ziagen oral solution, which is manufactured by GlaxoSmithKline. It is a pediatric formulation indicated for use in children ages 3 months to 13 years.

Because of its tentative approval, the generic version of abacavir will now be available for consideration for purchase and use outside the U.S. under the President's Emergency Plan for AIDS Relief (PEPFAR), which President Bush launched in 2003.

PEPFAR is currently providing $15 billion to fight the HIV/AIDS pandemic over five years, with a special focus on 15 of the world's hardest-hit countries. The program is designed to prevent 7 million new HIV infections, treat at least 2 million HIV-infected people and care for 10 million HIV-affected individuals.