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Entreprise · 12/04/20161 min de lecture
EMD Serono; Withdrawal of Approval of a New Drug Application for LUVERIS
Traduction automatique locale · Langue originale de la source
Résumé
The Food and Drug Administration (FDA or the Agency) is withdrawing approval of a new drug application (NDA) for LUVERIS (lutropin alpha for injection) held by EMD Serono, One Technology Place, Rockland, MA 02370. EMD Serono has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.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 →