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健友股份:子公司获得美国FDA来法莫林注射液药品生产场地转移注册批件
Xin Lang Cai Jing· 2026-02-26 08:13
Core Viewpoint - The announcement indicates that the application for the transfer of the production site for Lefamulin injection, 150mg/15mL, has been approved by the FDA, which is a significant development for the company and its product line [1] Group 1: Company Developments - The subsidiary Hong Kong Jianyou has successfully submitted a New Drug Application (NDA) to the FDA for Lefamulin injection [1] - The production site for Lefamulin injection has been transferred to Jianjin Pharmaceutical Co., Ltd., and this application has received FDA approval [1] - Lefamulin injection, marketed under the brand name XENLETA, was initially approved by the FDA on August 19, 2019 [1] Group 2: Market Context - Currently, there are no approved generic versions of Lefamulin injection available in the U.S. market [1]