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비즈니스 · 2026. 4. 20.1 분 읽기
Potential New Indication for Testosterone Replacement Therapy
로컬 자동 번역 · 원본 출처 언어
요약
The Food and Drug Administration (FDA, the Agency, or we) is announcing that we have reviewed information in published literature that seems promising regarding the potential use of testosterone replacement therapy (TRT) in the treatment of low libido in men with decreased libido associated with idiopathic hypogonadism. We encourage holders of approved TRT new drug applications (NDAs) that are interested in seeking approval for this new indication to contact FDA for further information regarding submission of a supplemental NDA, including data needed to support an approval.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →