BN Business News
Şirketinizi ekleyin →
Bu çeviri hazırlanıyor. Bu süre içinde İngilizce orijinal sürümü gösteriyoruz.

İş dünyası · 02.05.20221 dk okuma

Acrotech Biopharma LLC; Withdrawal of Approval of New Drug Application for MARQIBO (VinCRIStine Sulfate LIPOSOME Injection), 5 milligrams/5 milliliters

Yerel otomatik çeviri · Kaynağın orijinal dili

Özet

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.

Kaynağın orijinal dili: Federal Register — Food and Drug AdministrationOrijinal duyuruyu açın →