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| Diabetes Drug Report for November 2006 -- News About Diabetes | |
Novartis Says FDA Action on Approval of New Drug Galvus Delayed Until February
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Novartis AG on Nov. 13 said the U.S. Food and Drug Administration has put a hold on action on the oral diabetes drug Galvus for three more months while it seeks to determine whether problems encountered by animals taking the drug may pose risks to humans. Galvus is one of a new class of drugs, called DPP-IV, that enhance the body's ability to lower blood sugar. Merck & Co. last month received FDA approval for its DPP-IV drug, Januvia, and Novartis had been expecting approval of Galvus this month. Novartis said it has presented the FDA with additional evidence that skin findings, including lesions, identified in monkeys during a preclinical animal study have not been seen in clinical studies involving some 1,000 patients treated for type-2 diabetes. The additional three months will extend the FDA review period for Galvus from the end of November until the end of February 2007. "It was our decision," said Novartis spokesman John Gilardi. "It's a setback but we're still confident of getting it to the market quickly."
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We subscribe to the HONcode principles of the HON Foundation. Last Updated: 11/25/2006 Copyright 2004-2006 Medical Week News, Inc. All Rights Reserved
