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Negócios · 11/07/20221 min de leitura
Xellia Pharmaceuticals USA, LLC; Withdrawal of Approval of an Abbreviated New Drug Application for Bacitracin for Injection
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Resumo
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.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →