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Imprese · 08/08/20241 min di lettura
Flamingo Pharmaceuticals Ltd.; Proposal To Withdraw Approval of Two Abbreviated New Drug Applications; Opportunity for a Hearing
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Riepilogo
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of two abbreviated new drug applications (ANDAs) and is announcing an opportunity for the ANDA holder to request a hearing on this proposal. The basis for the proposal is that the ANDA holder has repeatedly failed to file required annual reports for those ANDAs.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →