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 · 1999/1/61 分で読めます
Dipyridamole; Drugs for Human Use; Drug Efficacy Study Implementation; Withdrawal of Approval of Abbreviated 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 conditional approval of abbreviated new drug applications (ANDA's) and pertinent parts of ANDA's for certain dipyridamole drug products. FDA is also declaring three unapproved dipyridamole drug products unlawful. FDA is withdrawing approval because there is a lack of substantial evidence that these drugs are effective for long-term therapy of chronic angina pectoris.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →