Dalvance FDA Approval History
FDA Approved: Yes (First approved May 23, 2014)
Brand name: Dalvance
Generic name: dalbavancin
Dosage form: Injection
Company: Allergan plc
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
Date | Article |
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Jul 23, 2021 | Approval Dalvance (dalbavancin) Receives FDA Approval to Treat Acute Bacterial Skin and Skin Structure Infections in Pediatric Patients |
Jan 21, 2016 | Approval Allergan Announces FDA Approval of Updated Label for New Dosing Regimen for Dalvance (dalbavancin) |
May 23, 2014 | Approval FDA Approves Dalvance (dalbavancin) to Treat Skin Infections |
Mar 31, 2014 | FDA Advisory Committee Unanimously Recommends Approval of Dalvance (dalbavancin) |
Nov 26, 2013 | Durata Therapeutics Announces FDA's Acceptance for Priority Review of NDA for Dalvance (dalbavancin hydrochloride) |
Sep 26, 2013 | Durata Therapeutics Announces NDA Submission for Dalbavancin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections (ABSSSI) |
Sep 9, 2008 | Pfizer Will Withdraw Global Marketing Applications for Dalbavancin to Conduct a New Trial |
Dec 21, 2007 | Pfizer Receives Approvable Letter from FDA for Dalbavancin |
Jun 2, 2005 | Vicuron Pharmaceuticals Receives Issued Patent for Dalbavancin Dosing by U.S. Patent and Trademark Office |
May 11, 2005 | Vicuron Pharmaceuticals Announces Extension of FDA Review of Dalbavancin New Drug Application |
Feb 24, 2005 | Vicuron Pharmaceuticals Granted Priority Review of Dalbavancin NDA by FDA in Complicated Skin and Soft Tissue Infections |
Dec 21, 2004 | Vicuron Pharmaceuticals Submits New Drug Application for Dalbavancin to U.S. Food and Drug Administration |
Further information
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