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비즈니스 · 2024. 8. 8.1 분 읽기
Flamingo Pharmaceuticals Ltd.; Proposal To Withdraw Approval of Two Abbreviated New Drug Applications; Opportunity for a Hearing
로컬 자동 번역 · 원본 출처 언어
요약
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.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →