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