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羅欣藥業(002793.SZ):左沙丁胺醇吸入溶液等5個藥品獲得美國FDA批准證書
格隆匯 09-02 19:14

格隆匯9月2日丨羅欣藥業(002793.SZ)公佈,公司下屬子公司羅欣安若維他藥業(成)有限公司(“羅欣安若維他”)於近日取得美國食品藥品監督管理局(“FDA”)下發的左沙丁胺醇吸入溶液等5個藥品的新藥簡略申請(“ANDA”)批准證書。

上述藥品系根據2019年12月31日羅欣安若維他與阿拉賓度製藥有限公司簽訂的《 ANDA TRANSFER AGREEMENT 》,阿拉賓度製藥有限公司向羅欣安若維他轉讓FDA藥品註冊批件。2021年8月6日,羅欣安若維他向FDA遞交ANDA持有人變更申請並於近日獲批。

左沙丁胺醇吸入溶液獲得FDA批准證書進一步鞏固公司在呼吸領域的優勢,有利於公司進一步拓展國際市場,符合公司國際化的發展戰略目標,對公司未來經營業績具有積極影響。同時,也為公司後續品通過國際註冊認證及開拓國際市場奠定了良好基礎。

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