Бизнес · 12.04.20161 мин чтения
EMD Serono; Withdrawal of Approval of a New Drug Application for LUVERIS
Локальный автоматический перевод · Язык оригинального источника
Краткое содержание
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 EMD Serono has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.