Vibativ Approval History

• FDA approved: Yes (First approved September 11th, 2009)
• Brand name: Vibativ
• Generic name: telavancin
• Company: Theravance Inc.
• Treatment for: Skin and Structure Infection

Vibativ (telavancin) is a bactericidal, once-daily injectable antibiotic for the treatment of complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains.

FDA Approval History for Vibativ

Date	Article
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 Advisory Committee

See also...

Vibativ (telavancin) Consumer Information

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