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Entreprise · 03/11/19941 min de lecture
Fujisawa USA, Inc; Withdrawal of Approval of a New Drug Application
Traduction automatique locale · Langue originale de la source
Résumé
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.
Langue originale de la source: Federal Register — Health and Human ServicesOuvrir le communiqué original →