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?????? ?? = ????????????? 5? ???? ?? ?? 2~3?? ????? ?? ??? ????? ????. ????? ?? 16???? 19???? ?? ???? ????? '??'? ????.

?? ???? ????? ?? 3? FUEL(Fontan Udenafil Exercise Longitudinal assessment) ??? ??? ?????? ????. ??? ? ?? ???? ???????(NIH)? ??? ?? ???? ???? ?? ??? ???? ??? ??? ????. ??? ?? ????? AHA(American Heart Association) 2019? ?????, ??? ?????? 11? 16? 11? 30? ??? ??.

??? ?????? ???? "FUEL ??? ????? ??? 12~18? ????? 400?? ???? 26?? ?????, ????? OLE(Open Label Extension) ? ?? ??? ?? ??? ???? ??? FALD(Fontan Associated Liver Disease)? ?? ?"??? ????.

???? ?? 11? AHA 2019?? ????? ?? 3? ???? ???? ?? ?? ?????(FDA)? ?? ??(NDA)? ??? ????. ????? ?? ??????? ?? ?? ????(Priority Review)? ??? ???? ???, ?? ?? ??? ?? 2~3??? ?? ??? ??? ? ?? ??. ??? ??? ?? ?? ?? ???(PRV)? ?? ??? ??? ????.

? ???? "???? ????? NDA ??, FDA ???? ??? ?? ????? ??? ??? ????"? ????.

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5 2 3 . 16 19 '' . 3 FUEL Fontan Udenafil Exercise Longitudinal assessment . NIH . AHA American Heart Association 2019 , 11 16 11 30 . " FUEL 12 18 400 26 , OLE Open Label Extension FALD Fontan Associated Liver Disease " . 11 AHA 2019 3 FDA NDA . Priority Review , 2 3 . PRV . " NDA , FDA " . '' '' amp mk. co. kr,

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