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Negocios · 31/12/20241 min de lectura
Flamingo Pharmaceuticals Ltd.; Withdrawal of Approval of Two Abbreviated New Drug Applications
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Resumen
The Food and Drug Administration (FDA or Agency) is withdrawing approval of two abbreviated new drug applications (ANDAs) from the holder of those ANDAs. The basis for the withdrawal is that the ANDA holder has repeatedly failed to file required annual reports for those ANDAs.
Idioma original de la fuente: Federal Register — Food and Drug AdministrationAbrir el comunicado original →