补充批准 · 说明书变更
批准信：Prior Approval；批准 Fruzaqla (fruquintinib) 处方信息 (PI) 及患者用药指南的标签更新，主要涉及肝毒性剂量调整建议、胰腺炎临床数据、女性不孕信息、肾功能不全药代动力学数据及非临床胚胎发育研究信息。
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批准信原文要点
This Prior Approval sNDA amended the Fruzaqla (fruquintinib) Prescribing Information (PI) in the following sections: Section 2.2 Dose Modifications for Adverse Reactions – updated recommendations regarding hepatotoxicity; Section 6.1 Clinical Trials Experience – included pancreatitis and increased pancreatic enzymes; Section 8.3 Females and Males of Reproductive Potential – included information on female infertility; Section 12.3 Pharmacokinetics – updated pharmacokinetics information in patients with renal impairment in the Specific Populations subsection; Section 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility – included information from a non-clinical embryonic development study; Section 17 Patient Counseling Information – included information about infertility
Labeling-Package Insert；Labeling-Patient Package Insert（PI；PPI）
申报事项：说明书/标签变更（Prior Approval）
变更信息：批准 Fruzaqla (fruquintinib) 处方信息 (PI) 及患者用药指南的标签更新，主要涉及肝毒性剂量调整建议、胰腺炎临床数据、女性不孕信息、肾功能不全药代动力学数据及非临床胚胎发育研究信息。
来源：官方文件