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Biotech / Medical : Versicor (VERS)

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From: nigel bates	5/11/2005 4:05:36 AM
	of 83

Vicuron Pharmaceuticals Announces Extension of FDA Review of Dalbavancin New Drug Application Wednesday May 11, 2:00 am ET Launch Still Expected In First Quarter of 2006 KING OF PRUSSIA, Pa., May 11 /PRNewswire-FirstCall/ -- Vicuron Pharmaceuticals Inc. (Nasdaq and MICU: Nuovo Mercato) today announced that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency expects to complete the priority review of the dalbavancin New Drug Application (NDA) on or before September 21, 2005, which is a three-month extension from the original Prescription Drug User Fee Act (PDUFA) action date of June 21, 2005. The extension is a result of the agency classifying recent responses to questions in the chemistry, manufacturing and controls (CMC) section of the NDA as a major amendment to the NDA. The agency has reset the action date to give it additional time to review this information. "We continue to expect to launch dalbavancin if approved in the first quarter of 2006," said George F. Horner III, President and Chief Executive Officer of Vicuron........

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