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Dalvance FDA Approval History

FDA Approved: Yes (First approved May 23, 2014)
Brand name: Dalvance
Generic name: dalbavancin
Dosage form: Injection
Company: AbbVie Inc.
Treatment for: Skin and Structure Infection

Dalvance (dalbavancin) is a second generation lipoglycopeptide antibiotic for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Grampositive microorganisms.

Development timeline for Dalvance

DateArticle
Jul 23, 2021Approval Dalvance (dalbavancin) Receives FDA Approval to Treat Acute Bacterial Skin and Skin Structure Infections in Pediatric Patients
Jan 21, 2016Approval Allergan Announces FDA Approval of Updated Label for New Dosing Regimen for Dalvance (dalbavancin)
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

See also

Dalvance (dalbavancin) Consumer information

Further information

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