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 |
|---|
| 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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