WASHINGTON, Aug. 4 (UPI) -- Indian drug maker Ranbaxy Laboratories plans to seek U.S. approval for its generic combination AIDS drug so U.S. money can supply it to Third World patients.
Ranbaxy's drug, which is unlikely to be sold in the United States because of patent restrictions, combines generic versions of three brand-name AIDS medications and is intended for developing nations.
The company said it will submit its application to the Food and Drug Administration before the end of the year.
AIDS-treatment groups have pressured U.S. officials to allow its multibillion AIDS fund to buy such generic AIDS pills. But the Bush administration said makers of generic AIDS drugs should first prove to the FDA their drugs are safe and of high-quality.
So far, the FDA hasn't reviewed the Ranbaxy drug due to patent restrictions that would prevent it from being sold in the United States. But under an expedited approval process the FDA announced in May, the agency has said it will approve drugs for use globally -- even if they are protected by U.S. patents.
Once an application is complete, the FDA promises a four- to six-week review.
