US clears oral AIDS drug for use overseas

WASHINGTON (Reuters) – U.S. health officials on Thursday
granted tentative approval for a generic liquid version of the
AIDS drug AZT, allowing it to be used overseas under a U.S.
program to fight the deadly virus.

The generic oral version of GlaxoSmithKline Plc’s drug
zidovudine, made by India-based drugmaker Aurobindo Pharma
Ltd., is the latest in a string of approvals for the program.

However, the generic drug will not be available in the
United States because of patent protections.

President George W. Bush launched a five-year, $15 billion
program in 2003 aims to pay for treatment for 2 million AIDS
sufferers and provide care for 10 million others in 15
countries, mostly in Africa.

Glaxo sells its drug under the name Retrovir, or AZT. The
nucleoside reverse transcriptase inhibitor helps keep the AIDS
virus from multiplying.

Aurobindo’s version of AZT meets the FDA’s standards, the
agency said, making it eligible for purchase and use in other
countries under the Emergency Plan for AIDS Relief.

The agency approved Indian drugmaker Ranbaxy Laboratories
Ltd’s generic version of AZT in July as part of the U.S.
program.