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비즈니스 · 2021. 3. 12.1 분 읽기
Withdrawal of Approval of Five Abbreviated New Drug Applications for Bacitracin for Injection
로컬 자동 번역 · 원본 출처 언어
요약
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is withdrawing approval of five abbreviated new drug applications (ANDAs) from multiple holders. Akorn Inc. (Akorn), Mylan ASI LLC (Mylan), Pfizer Inc. (Pfizer), X-GEN Pharmaceuticals, Inc. (X-GEN), and Fresenius Kabi USA, LLC (Fresenius) have requested withdrawal of approval of their respective applications and have waived their opportunity for a hearing.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →