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商业 · 2021/3/121 分钟阅读
Withdrawal of Approval of Five Abbreviated New Drug Applications for Bacitracin for Injection
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摘要
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.
来源原始语言: Federal Register — Food and Drug Administration打开原始公告 →