雙成藥業(002693.SZ):注射用生長抑素已通過仿製藥質量和療效一致性評價
格隆匯11月11日丨雙成藥業(002693.SZ)公佈,公司於近日收到國家藥品監督管理局核准簽發的注射用生長抑素《藥品補充申請批准通知書》。公司產品注射用生長抑素已通過仿製藥質量和療效一致性評價。
注射用生長抑素適用於嚴重急性食道靜脈曲張出血;嚴重急性胃或十二指腸潰瘍出血,或併發急性糜爛性胃炎或出血性胃炎;胰腺手術後併發症的預防和治療;胰、膽和腸瘻的輔助治療;糖尿病酮症酸中毒的輔助治療。
截止目前,公司已有注射用胸腺法新、注射用比伐蘆定、注射用生長抑素3個多肽產品通過一致性評價。注射用生長抑素通過一致性評價,證明公司該產品在質量和療效上與原研藥品一致,同時為公司後續產品開展一致性評價工作積累了寶貴經驗。
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