この記事の翻訳を準備しています。それまでの間、英語の原文を表示します。
ビジネス · 2022/5/21 分で読めます
Acrotech Biopharma LLC; Withdrawal of Approval of New Drug Application for MARQIBO (VinCRIStine Sulfate LIPOSOME Injection), 5 milligrams/5 milliliters
ローカル自動翻訳 · 情報源の原言語
概要
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.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →