再生元/拜耳“阿柏西普 8 mg”两项申请被 FDA 延期

新浪医药08-22

当地时间 8 月 20 日，再生元宣布，FDA 已将两份阿柏西普注射液（8 毫克）监管申请的目标行动日期延长至 2025 年第四季度。这两份申请包括：一份阿柏西普注射液（ 8 毫克）预充式注射器的化学、生产和控制(CMC)预先批准补充文件(PAS)；以及一份用于治疗视网膜静脉阻塞(RVO)后黄斑水肿患者的补充生物制品许可申请(sBLA)，该申请的原本 PDUFA 日期为 8 月 19 日。FDA ...

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