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商业 · 2024/8/81 分钟阅读
Flamingo Pharmaceuticals Ltd.; Proposal To Withdraw Approval of Two Abbreviated New Drug Applications; Opportunity for a Hearing
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摘要
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.
来源原始语言: Federal Register — Food and Drug Administration打开原始公告 →