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비즈니스 · 2022. 5. 2.1 분 읽기
Acrotech Biopharma LLC; Withdrawal of Approval of New Drug Application for MARQIBO (VinCRIStine Sulfate LIPOSOME Injection), 5 milligrams/5 milliliters
로컬 자동 번역 · 원본 출처 언어
요약
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.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →