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Entreprise · 25/04/20121 min de lecture
AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of a New Drug Application for IRESSA
Traduction automatique locale · Langue originale de la source
Résumé
The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for IRESSA (gefitinib) Tablets held by AstraZeneca Pharmaceuticals LP (AstraZeneca), 1800 Concord Pike, P.O. Box 8355, Wilmington, DE 19803-8355. AstraZeneca has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →