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news.The FDA has delayed its review of Vicuron Pharmaceuticals' new drug application for the antibiotic dalbavancin by three months in order to review amendments to the filing.
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The FDA notified Vicuron that it 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 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.
Despite the delay, Vicuron said that it still expects to launch dalbavancin in the first quarter of 2006, if approved.
Vicuron Pharmaceuticals is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing vital medicine for seriously ill patients.
Dalbavancin is a novel intravenous antibiotic for the treatment of serious Gram-positive infections. The dalbavancin NDA is one of two currently pending with the FDA, with the other concerning the company’s novel antifungal agent, anidulafungin.