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 · 2021/3/121 分で読めます
Withdrawal of Approval of Five Abbreviated New Drug Applications for Bacitracin for Injection
ローカル自動翻訳 · 情報源の原言語
概要
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is withdrawing approval of five abbreviated new drug applications (ANDAs) from multiple holders. Akorn Inc. (Akorn), Mylan ASI LLC (Mylan), Pfizer Inc. (Pfizer), X-GEN Pharmaceuticals, Inc. (X-GEN), and Fresenius Kabi USA, LLC (Fresenius) have requested withdrawal of approval of their respective applications and have waived their 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 →