ビジネス · 2012/1/181 分で読めます
Determination That PREZISTA (darunavir) Tablets, 300 Milligrams Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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The Food and Drug Administration (FDA) has determined that PREZISTA (darunavir) Tablets, 300 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for darunavir tablets, 300 mg, if all other legal and regulatory requirements are met.