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Negócios · 31/12/20241 min de leitura
Flamingo Pharmaceuticals Ltd.; Withdrawal of Approval of Two Abbreviated New Drug Applications
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Resumo
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 da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →