Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
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Wall Street Journal - August 3, 2004
Sarah Lueck and David P. Hamilton, Staff Reporters of The Wall Street Journal
Meanwhile, the FDA approved two other combination AIDS medications: Truvada by Gilead Sciences Inc. and Epzicom by GlaxoSmithKline PLC. Both Truvada and Epzicom are single pills containing two existing AIDS drugs.
Most patients will still need to take a third drug to effectively control the AIDS virus, although Gilead is working with Bristol-Myers Squibb Co. and Merck & Co. to develop such a three-in-one pill.
The Ranbaxy drug, which is unlikely to be sold in the U.S. because of patent restrictions, combines generic versions of three brand-name AIDS medications. It is intended largely for developing nations.
Ranbaxy said it will submit its application to the FDA before the end of the year. AIDS-treatment groups have been pushing for wider access to the pill for developing countries because it is cheaper than its brand-name components and easier for patients to use. Advocates have pressured the U.S. to allow its multibillion AIDS fund to purchase such three-in-one pills.
But the Bush administration, echoing arguments made by the pharmaceutical industry, said makers of generic AIDS drugs should prove to the FDA that their drugs are safe and high-quality before the U.S. AIDS fund will purchase them. So far, the FDA hasn't reviewed the Ranbaxy drug due to patent restrictions that would prevent it from being sold in the U.S.
Under an expedited approval process that 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 has promised a review of four to six weeks.
FDA Commissioner Lester Crawford said the agency had "gained important scientific knowledge" while reviewing the Gilead and Glaxo drugs that would be "useful" as the agency reviews other combinations.
Write to Sarah Lueck at sarah.lueck@wsj.com and David P. Hamilton at david.hamilton@wsj.com
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