雙成藥業(002693.SZ):子公司鹽酸美金剛片ANDA獲美國FDA上市許可
格隆匯4月7日丨雙成藥業(002693.SZ)公佈,公司控股子公司寧波雙成於近日收到美國食品和藥品監督管理局(“FDA”)的通知,寧波雙成受讓寧波守正的鹽酸美金剛片的簡化新藥申請(“ANDA”)已獲得美國FDA的上市許可批准。鹽酸美金剛片是一種治療中重度至重度阿爾茨海默型老年痴呆症的藥品。
美國FDA審評了鹽酸美金剛片ANDA,認可了申報信息的全面性和科學性,認為公司該產品(鹽酸美金剛片USP,5mg和10mg)與原研藥公司的參比藥物Namenda(5mg和10mg)在生物等效性和療效上是一致的。
公司表示,寧波雙成ANDA通過美國FDA批准,標誌着寧波雙成擁有的鹽酸美金剛片在安全性和有效性上達到了原研水平,其固體制劑的GMP管理滿足美國FDA的要求,對公司未來經營業績具有一定積極的影響。
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