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亚硒酸注射液(600 mcg/10 mL)
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健友股份子公司亚硒酸注射液获得美国FDA批准
Xin Lang Cai Jing· 2026-02-04 09:24
Core Viewpoint - The company announced that its subsidiary, Jianjin Pharmaceutical Co., Ltd., has received ANDA approval from the U.S. FDA for sodium selenite injection (600 mcg/10 mL), which is expected to positively impact the company's operating performance [1] Group 1: Product Approval - The approved drug is indicated for adult and pediatric patients requiring parenteral nutrition, serving as a source of selenium when oral or enteral nutrition is not feasible, insufficient, or contraindicated [1] - Currently, there are five approved generic versions of sodium selenite injection available in the U.S. market [1] Group 2: Financial Investment - The company has invested approximately RMB 6.5605 million in the research and development of this project [1]