Dalvance

Treatment for Skin and Structure Infection

Update: Dalvance (dalbavancin) Now FDA Approved - May 23, 2014

Vicuron Pharmaceuticals Announces Extension of FDA Review of Dalbavancin New Drug Application


Launch Still Expected In First Quarter of 2006

KING OF PRUSSIA, Pa., May 11, 2005 -- 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.

About Vicuron Pharmaceuticals
Vicuron Pharmaceuticals is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing vital medicine for seriously ill patients. The company has two New Drug Applications pending with the U.S. Food and Drug Administration for its lead products, dalbavancin, a novel intravenous antibiotic for the treatment of serious Gram-positive infections, and anidulafungin, a novel antifungal agent. Vicuron's versatile research engine integrates industry-leading expertise in functional genomics, mechanism-based drug design and combinatorial and medicinal chemistry. These approaches are yielding promising novel and next-generation compounds, many of which are in the later stages of preclinical development. In addition, the company has research collaborations with leading pharmaceutical companies, such as Pfizer.

Posted: May 2005

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