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 · 2024/8/151 分で読めます
Cubist Pharmaceuticals LLC; Withdrawal of Approval of a New Drug Application for ENTEREG (Alvimopan) Capsules, 12 Milligrams
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概要
The Food and Drug Administration (FDA or Agency) is withdrawing approval of a new drug application (NDA) for ENTEREG (alvimopan) Capsules, 12 milligrams (mg), held by Cubist Pharmaceuticals LLC, 126 East Lincoln Ave., Rahway, NJ 07065 (Cubist). Cubist notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →