翰宇药业(300199.SZ)：利拉鲁肽注射液获得美国FDA暂定批准

智通财经06-24

智通财经APP讯，翰宇药业(300199.SZ)发布公告，公司收到美国食品药品监督管理局(简称“FDA”)的通知，由翰宇药业及Hikma Pharmaceuticals USA,Inc.联合向FDA申报的利拉鲁肽注射液新药简略申请(ANDA，即美国仿制药申请)已获得暂定批准。据悉，暂定批准指FDA已经完成仿制药的所有审评要求，即药品经审查，质量、安全和有效性已符合在美国上市的标准，出于专利权和/或...

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