Keywords: USA, FDA, Theravance, Astelas, Vibativ
US FDA says Theravance/Astellas’ Vibativ NDA for NP is incomplete
Article | 29 January 2010
US drug developer Theravance says that it has received from a letter from the Food and Drug Administration indicating that the firm’s response to the November 2009 Complete Response letter for the Vibativ (telavancin) New Drug Application for the treatment of nosocomial pneumonia (NP) is incomplete and that the review clock will not start until the FDA receives a complete response.
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