Fujisawa USA, Inc; Withdrawal of Approval of a New Drug Application

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The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) held by Fujisawa USA, Inc., Parkway North Center, Three Parkway North, Deerfield, IL 60015-2548 (Fujisawa). FDA is withdrawing approval of this application because of questions raised about the reliability of the data and information submitted to FDA in support of the application. Marketing of the drug has been discontinued, and Fujisawa has voluntarily requested withdrawal of approval of the application and has waived its opportunity for a hearing.