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
|May 9, 2016|| Theravance Biopharma Announces FDA Approval of Expanded Label for Vibativ (telavancin)|
|Jun 21, 2013|| FDA Approves Vibativ for Hospitalized Patients with Bacterial Pneumonia|
|Sep 13, 2009|| 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
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