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Negocios · 24/4/20261 min de lectura
Egis Pharmaceuticals Limited, et al.; Withdrawal of Approval of Three Abbreviated New Drug Applications
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Resumen
The Food and Drug Administration (FDA or Agency) is withdrawing approval of three abbreviated new drug applications (ANDAs) from the holders of those ANDAs. The basis for the withdrawal is that the ANDA holders have repeatedly failed to file required annual reports for those ANDAs.
Idioma original de la fuente: Federal Register — Food and Drug AdministrationAbrir el comunicado original →