联邦制药:左氧氟沙星滴眼液通过中国国家药品监督管理局上市审批

Core Viewpoint - The approval of Levofloxacin eye drops by the National Medical Products Administration of China marks a significant advancement for the company in the ophthalmic product sector, enhancing its competitive position in the field of anti-infection treatments [1] Group 1: Product Approval - The company's wholly-owned subsidiary, Zhuhai United Pharmaceutical Co., Ltd., received approval for Levofloxacin eye drops (0.488% concentration, 5ml: 24.4mg) from the National Medical Products Administration of China, with the approval number H20256135 [1] - Levofloxacin is a third-generation fluoroquinolone antibiotic that inhibits bacterial DNA gyrase and topoisomerase IV, effectively blocking bacterial DNA synthesis and demonstrating significant antibacterial activity against various Gram-positive and Gram-negative bacteria [1] Group 2: Clinical Applications - Levofloxacin eye drops are widely used in clinical settings for the treatment of conditions such as blepharitis, meibomian gland inflammation, dacryocystitis, conjunctivitis, meibomianitis, and keratitis, as well as for sterile treatment during ophthalmic surgeries [1] Group 3: Market Impact - The approval of Levofloxacin eye drops will further expand the company's ophthalmic product portfolio and strengthen its leading position in the field of anti-infection treatments [1] - The product is classified as a Category A drug in the National Medical Insurance Directory (2024 edition), indicating its importance and potential for market success [1] - The company is committed to advancing new product development to provide comprehensive and high-quality medication solutions for clinical use, which is expected to generate greater returns for the company and its shareholders [1]

UNITED LAB-联邦制药:左氧氟沙星滴眼液通过中国国家药品监督管理局上市审批 - Reportify