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FDAはセマグルチド、チルゼパチド、リラグルチドを503Bバルクリストから除外することを提案

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-- 米国食品医薬品局（FDA）は木曜日、セマグルチド、チルゼパチド、リラグルチドを503Bバルク医薬品リストから除外する案を発表した。バルク原薬からこれらの薬剤を調剤する外部委託施設の必要性は臨床的に認められないとの判断に基づいている。 ノボノルディスク（NVO）は、2型糖尿病治療薬「オゼンピック」および慢性体重管理薬「ウェゴビー」として販売されているセマグルチドと、2型糖尿病治療薬「ビクトーザ」および慢性体重管理薬「サクセンダ」として販売されているリラグルチドを製造している。イーライリリー（LLY）は、2型糖尿病治療薬「ムンジャロ」および慢性体重管理薬「ゼプバウンド」として販売されているチルゼパチドを製造している。 FDAによると、通常、外部委託施設は、バルク原薬が503Bバルク医薬品リストに掲載されている場合、または調剤・流通・調剤時に調剤薬がFDAの医薬品不足リストに掲載されている場合を除き、バルク原薬を使用して薬剤を調剤することはできない。 ノボノルディスクとイーライリリーは、MTニュースワイヤーズからのコメント要請にすぐには応じなかった。

Price: $42.48, Change: $+2.19, Percent Change: +5.44%

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