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Orbactiv Approval History

  • FDA approved: Yes (First approved August 6th, 2014)
  • Brand name: Orbactiv
  • Generic name: oritavancin
  • Dosage form: Injection
  • Company: The Medicines Company
  • Treatment for: Skin and Structure Infection

Orbactiv (oritavancin) is a semi-synthetic lipoglycopeptide antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

Development History and FDA Approval Process for Orbactiv

Aug  6, 2014Approval FDA Approves Orbactiv (oritavancin) to Treat Skin and Skin Structure Infections
Feb 20, 2014FDA Accepts Filing of NDA for IV Antibiotic Oritavancin with Priority Review
Dec  9, 2008FDA Issues Complete Response Letter for Oritavancin
Oct 15, 2008Targanta Announces Review of Oritavancin at FDA Anti-Infective Drugs Advisory Committee Meeting
Apr  9, 2008Targanta Announces FDA Acceptance of Oritavancin New Drug Application
Feb 11, 2008Targanta Submits Oritavancin New Drug Application

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