DalvanceTreatment for Skin and Structure Infection
Update: Dalvance (dalbavancin) Now FDA Approved - May 23, 2014
Pfizer Receives Approvable Letter from FDA for Dalbavancin
NEW YORK--(BUSINESS WIRE)--Dec 21, 2007 - Pfizer Inc today announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) issued for dalbavancin HCl, Pfizer's once-weekly two-dose antibiotic under FDA review for the treatment of adult patients with complicated skin and skin structure infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA).
The FDA recently published a draft guidance on studies designed to show non-inferiority as a basis for approval of antibacterial drug products and has requested that Pfizer provide additional data with regard to dalbavancin. Pfizer is working with the FDA to respond to these new requirements.
Separately, the FDA approvable letter refers to deviations from current good manufacturing practices (cGMP) at a third-party manufacturer, not specifically related to dalbavancin. The third-party manufacturer is working with the FDA to resolve outstanding manufacturing issues.
Pfizer is also addressing a question from the FDA regarding length of storage time following reconstitution of dalbavancin.
Dalbavancin, a member of the glycopeptide class of antibiotics, represents an important addition to Pfizer's broad portfolio of antibacterial products and product candidates. Dalbavancin was acquired by Pfizer in September 2005 as part of its acquisition of Vicuron Pharmaceuticals, Inc.
Pfizer has a long history of developing new medicines for treating infectious diseases and remains committed to providing physicians with this important new treatment option for skin infections caused by MRSA. FDA-approved products, including Pfizer's Zyvox (linezolid IV/Oral), are currently available for the treatment of complicated skin and skin structure infections caused by MRSA.
MRSA is a virulent and potentially deadly bacterium, and MRSA infections are on the rise in hospitals, long-term care facilities and within communities. MRSA is resistant to many classes of commonly used antibiotics and can cause several types of infections, with skin infections being the most common. The Infectious Diseases Society of America (IDSA) has included MRSA on a reported Hit List of top-priority, dangerous drug resistant microbes that require additional research and new treatments.
DISCLOSURE NOTICE: The information contained in this release is as of December 21, 2007. Pfizer assumes no obligation to update any forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information that involves substantial risks and uncertainties regarding a product candidate that is under review by the United States Food and Drug Administration (FDA), including its potential benefits. Such risks and uncertainties include, among other things, whether and when the FDA will approve the product candidate, the FDA's decisions regarding labeling and other matters that could affect its availability or commercial potential, as well as competitive developments.
A further list and description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2006 and in its reports on Form 10-Q and Form 8-K.
Posted: December 2007
- FDA Approves Dalvance (dalbavancin) to Treat Skin Infections - May 23, 2014
- FDA Advisory Committee Unanimously Recommends Approval of Dalvance (dalbavancin) - March 31, 2014
- Durata Therapeutics Announces FDA's Acceptance for Priority Review of NDA for Dalvance (dalbavancin hydrochloride) - November 26, 2013
- Durata Therapeutics Announces NDA Submission for Dalbavancin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections (ABSSSI) - September 26, 2013
- Pfizer Will Withdraw Global Marketing Applications for Dalbavancin to Conduct a New Trial - September 9, 2008
- Vicuron Pharmaceuticals Receives Issued Patent for Dalbavancin Dosing by U.S. Patent and Trademark Office - June 2, 2005
- Vicuron Pharmaceuticals Announces Extension of FDA Review of Dalbavancin New Drug Application - May 11, 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