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İş dünyası · 11.07.20221 dk okuma
Xellia Pharmaceuticals USA, LLC; Withdrawal of Approval of an Abbreviated New Drug Application for Bacitracin for Injection
Yerel otomatik çeviri · Kaynağın orijinal dili
Özet
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.
Kaynağın orijinal dili: Federal Register — Food and Drug AdministrationOrijinal duyuruyu açın →