Esta traducción se está preparando. Mientras tanto, mostramos temporalmente la versión original en inglés.
Negocios · 2/5/20221 min de lectura
Acrotech Biopharma LLC; Withdrawal of Approval of New Drug Application for MARQIBO (VinCRIStine Sulfate LIPOSOME Injection), 5 milligrams/5 milliliters
Traducción automática local · Idioma original de la fuente
Resumen
The Food and Drug Administration (FDA or Agency) is withdrawing approval of new drug application (NDA) for MARQIBO (vinCRIStine sulfate LIPOSOME injection), 5 milligrams (mg)/5 milliliters (mL), held by Acrotech Biopharma LLC (Acrotech), 29 Princeton Hightstown Rd., East Windsor, NJ 08520. Acrotech has voluntarily requested that FDA withdraw approval of this application and has waived its opportunity for a hearing.
Idioma original de la fuente: Federal Register — Food and Drug AdministrationAbrir el comunicado original →