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路透10月25日 - 美国食品和药物管理局周五表示，该局已批准Iterum Therapeutics公司的 口服抗生素用于治疗成年女性的一种尿路感染$(UTI)$。
这种常见的膀胱细菌感染主要影响泌尿道解剖结构正常的妇女。
据该公司称，美国有一半的妇女在一生中至少经历过一次无并发症的UTI。尽管已批准了多种抗生素，但由于副作用和耐药菌的增加，一些患者的选择可能有限。
监管机构是在 2021 年拒绝批准该药物、要求提供更多数据后做出这一决定的。该公司随后重新提交了申请，因为后期试验显示该药物耐受性良好，没有发现任何安全问题。
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