FDAnews Drug Daily Bulletin

FIRST GENERIC HIV/AIDS CAPSULE APPROVED FOR U.S. MARKET

April 11, 2006
A A

The FDA has approved Indian drugmaker Aurobindo Pharma's generic version of GlaxoSmithKline's (GSK) HIV/AIDS drug Retrovir in capsule form. The product is the first generic HIV/AIDS drug in capsule form the FDA has approved for the U.S. market.

GSK's patents on all dosage forms of Retrovir (zidovudine) expired in September 2005.

Zidovudine is in the class of drugs known as nucleoside reverse transcriptase inhibitors, which inhibit AIDS virus reproduction. As an antiretroviral drug, zidovudine is intended for use with other antiretroviral agents for the treatment of HIV-1 infection.