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 · 2001/9/251 分で読めます
Solvay Pharmaceuticals, Inc.; Withdrawal of Approval of Two New Drug Applications
ローカル自動翻訳 · 情報源の原言語
概要
The Food and Drug Administration (FDA) is withdrawing approval of two new drug applications (NDAs) held by Solvay Pharmaceuticals, Inc., 901 Sawyer Rd., Marietta, GA 30062. In 1997, the agency informed Solvay of its intention to assess the validity of data and information in all of Solvay's pending and approved applications. However, Solvay does not intend to conduct validity assessments of the two NDAs named in this notice because the products are no longer marketed. Solvay has agreed to permit FDA to withdraw approval of the applications, thereby waiving 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 →