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 · 2014/2/201 分で読めます
Phenylpropanolamine; Withdrawal of Approval of 13 New Drug Applications and 7 Abbreviated New Drug Applications
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概要
The Food and Drug Administration (FDA) is withdrawing approval of 13 new drug applications (NDAs) and 7 abbreviated new drug applications (ANDAs) for products containing phenylpropanolamine. The basis for the withdrawals is that the products are no longer considered safe due to the association of phenylpropanolamine use with increased risk of hemorrhagic stroke. The holders of these NDAs and ANDAs 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 →