DalbavancinTreatment for Skin and Structure Infection
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
- Pfizer Will Withdraw Global Marketing Applications for Dalbavancin to Conduct a New Trial - September 9, 2008
- Pfizer Receives Approvable Letter from FDA for Dalbavancin - December 21, 2007
- Vicuron Pharmaceuticals Receives Issued Patent for Dalbavancin Dosing by U.S. Patent and Trademark Office - June 2, 2005
- Vicuron Pharmaceuticals Granted Priority Review of Dalbavancin NDA by FDA in Complicated Skin and Soft Tissue Infections - February 24, 2005
- Vicuron Pharmaceuticals Submits New Drug Application for Dalbavancin to U.S. Food and Drug Administration - December 21, 2004