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雙成藥業(002693.SZ):醋酸奧曲肽注射液ANDA獲得美國FDA上市許可
格隆匯 05-06 16:17

格隆匯5月6日丨雙成藥業(002693.SZ)公佈,公司於近日收到美國食品和藥品監督管理局(簡稱“FDA”)的通知,公司向美國FDA提交的醋酸奧曲肽注射液簡化新藥申請(簡稱“ANDA”)已獲得美國FDA的上市許可批准。美國FDA對公司遞交的醋酸奧曲肽注射液ANDA申報資料進行了全面技術審評,認可了申報信息的全面性和科學性。

醋酸奧曲肽注射液適用於控制手術治療或放射治療不能充分控制病情的肢端肥大症患者的症狀並降低患者的生長激素(GH)和胰島素樣生長因子-1(IGF-1)血漿水平。治療不能或不願手術的肢端肥大症患者,或者治療放射治療尚未生效的間歇期肢端肥大症患者;緩解與功能性胃腸胰腺(GEP)內分泌腫瘤有關的症狀;預防胰腺手術後併發症;肝硬化患者胃-食管靜脈曲張所致出血的緊急治療,止血和預防再出血,與內窺鏡硬化劑等特殊治療聯用。

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