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Lupin公司的甘油苯丁酸酯口服液获得美国FDA批准

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-- 据周二提交给印度证券交易所的文件显示,制药公司 Lupin(NSE:LUPIN,BOM:500257)已获得美国食品药品监督管理局 (FDA) 对其甘油苯丁酸酯口服液的批准。 甘油苯丁酸酯口服液与 Horizon Therapeutics U.S. Holdings 的参比制剂 Ravicti 口服液具有生物等效性,后者用于治疗尿素循环障碍患者的慢性疾病。 根据 IQVIA 的估计,截至 2025 年 12 月,甘油苯丁酸酯口服液的年销售额为 3.37 亿美元。

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