Dalvance Approval History

  • FDA approved: Yes (First approved May 23rd, 2014)
  • Brand name: Dalvance
  • Generic name: dalbavancin
  • Company: Durata Therapeutics, Inc.
  • Treatment for: Skin and Structure Infection

Dalvance (dalbavancin) is a second generation lipoglycopeptide antibiotic for the treatment of adult patients with complicated skin and skin structure infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA).

FDA Approval History for Dalvance

DateArticle
May 23, 2014Approval FDA Approves Dalvance (dalbavancin) to Treat Skin Infections
Mar 31, 2014FDA Advisory Committee Unanimously Recommends Approval of Dalvance (dalbavancin)
Nov 26, 2013Durata Therapeutics Announces FDA's Acceptance for Priority Review of NDA for Dalvance (dalbavancin hydrochloride)
Sep 26, 2013Durata Therapeutics Announces NDA Submission for Dalbavancin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Sep  9, 2008Pfizer Will Withdraw Global Marketing Applications for Dalbavancin to Conduct a New Trial
Dec 21, 2007Pfizer Receives Approvable Letter from FDA for Dalbavancin
Jun  2, 2005Vicuron Pharmaceuticals Receives Issued Patent for Dalbavancin Dosing by U.S. Patent and Trademark Office
May 11, 2005Vicuron Pharmaceuticals Announces Extension of FDA Review of Dalbavancin New Drug Application
Feb 24, 2005Vicuron Pharmaceuticals Granted Priority Review of Dalbavancin NDA by FDA in Complicated Skin and Soft Tissue Infections
Dec 21, 2004Vicuron Pharmaceuticals Submits New Drug Application for Dalbavancin to U.S. Food and Drug Administration

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