Esta traducción se está preparando. Mientras tanto, mostramos temporalmente la versión original en inglés.
Negocios · 28/11/20111 min de lectura
Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for MYLOTARG
Traducción automática local · Idioma original de la fuente
Resumen
The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for MYLOTARG (gemtuzumab ozogamicin) for Injection, held by Wyeth Pharmaceuticals, Inc. (Wyeth), 500 Arcola Rd., Collegeville, PA 19426. Wyeth, now a part of Pfizer, Inc., has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.
Idioma original de la fuente: Federal Register — Health and Human ServicesAbrir el comunicado original →