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 · 2022/9/221 分で読めます
Determination That Prescription NIX (Permethrin) 1% Topical Creme Rinse Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
ローカル自動翻訳 · 情報源の原言語
概要
The Food and Drug Administration (FDA, Agency, or we) has determined that prescription NIX (permethrin) 1% topical creme rinse was not withdrawn from sale for reasons of safety or effectiveness. However, because NIX (permethrin) 1% topical creme rinse has been approved for nonprescription use, NIX and any generic product referencing prescription NIX would be misbranded under FDA regulations if marketed with the "Rx only" symbol. Moreover, FDA will not approve abbreviated new drug applications (ANDAs) referencing prescription NIX (permethrin) 1% topical creme rinse.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →