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商业 · 2022/7/111 分钟阅读
Xellia Pharmaceuticals USA, LLC; Withdrawal of Approval of an Abbreviated New Drug Application 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 the approval of an abbreviated new drug application (ANDA) for bacitracin for injection, 50,000 units/vial (ANDA 203177), held by Xellia Pharmaceuticals USA, LLC (Xellia). Xellia has requested withdrawal of approval of this application and has waived its opportunity for a hearing.
来源原始语言: Federal Register — Food and Drug Administration打开原始公告 →