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Theravance’s Persistence On Telavancin Rewarded With Positive Cmte. Vote

 
• By Sue Sutter

FDA’s Anti-Infective Drugs Advisory Committee endorsed Vibativ for limited use in nosocomial pneumonia. The committee was convened at the recommendation of Office of New Drugs Director John Jenkins, who denied the company’s appeal of a second “complete response” letter but urged the NDA be re-evaluated.

Innoviva Inc.’s experience with the nosocomial pneumonia NDA for Vibativ (telavancin) may give other sponsors hope that all is not lost when a review division repeatedly rejects an application.

The company has waged an almost four-year regulatory battle to secure approval of its lipoglycopeptide antibacterial for nosocomial pneumonia

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