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Vibativ Approval History

FDA Approved: Yes (First approved September 11, 2009)
Brand name: Vibativ
Generic name: telavancin
Dosage form: Injection
Company: Theravance, Inc.
Treatment for: Skin and Structure Infection, Pneumonia

Vibativ (telavancin) is a bactericidal, once-daily injectable antibiotic for the treatment of complicated skin and skin structure infections (cSSSI), and hospital-acquired and ventilator-associated bacterial pneumonia.

Development History and FDA Approval Process for Vibativ

DateArticle
May  9, 2016Approval Theravance Biopharma Announces FDA Approval of Expanded Label for Vibativ (telavancin)
Jun 21, 2013Approval FDA Approves Vibativ for Hospitalized Patients with Bacterial Pneumonia
Sep 13, 2009Approval Theravance and Astellas Announce FDA Approval of Vibativ (telavancin) for the Treatment of Complicated Skin and Skin Structure Infections
Apr 25, 2009FDA Accepts for Review Theravance's Complete Response Submission for Telavancin for the Treatment of Complicated Skin and Skin Structure Infections
Apr  7, 2009Theravance Announces FDA Acceptance of Telavancin NDA for the Treatment of Hospital-Acquired Pneumonia
Feb 27, 2009Theravance Receives Complete Response Letter on the Telavancin New Drug Application for the Treatment of cSSSI
Jan 27, 2009Theravance Submits U.S. NDA for Telavancin for the Treatment of Hospital-Acquired Pneumonia
Nov 20, 2008Theravance Reports Favorable Outcome of FDA Advisory Committee Meeting on Telavancin for the Treatment of Complicated Skin and Skin Structure Infections
Mar  6, 2008FDA Accepts for Review Theravance's Complete Response to Approvable Letter for Telavancin for the Treatment of Complicated Skin and Skin Structure Infections
Jan  2, 2008Theravance Receives Notice of Possible Telavancin Review by FDA Advisory Committee

Further information

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