Esta traducción se está preparando. Mientras tanto, mostramos temporalmente la versión original en inglés.
Negocios · 25/4/20121 min de lectura
Sanofi-aventis, U.S., LLC; Withdrawal of Approval of a New Drug Application for OFORTA
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 OFORTA (fludarabine phosphate) Tablets held by sanofi-aventis, U.S., LLC (sanofi-aventis), 55 Corporate Dr., Bridgewater, NJ 08807-0977. Sanofi-aventis has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.
Idioma original de la fuente: Federal Register — Food and Drug AdministrationAbrir el comunicado original →