天宇股份：子公司制剂产品首次获得美国FDA批准文号

Core Viewpoint - Tianyu Co., Ltd. announced that its wholly-owned subsidiary, Node Pharmaceuticals, has received approval from the U.S. FDA for the abbreviated new drug application (ANDA) of Olmesartan Medoxomil and Hydrochlorothiazide tablets, marking a significant milestone for the company in entering the U.S. market [1] Group 1 - The approved drug is primarily used for the treatment of hypertension and was developed by Cosette Pharmaceuticals, Inc., which launched it in the U.S. in June 2003 [1] - Node Pharmaceuticals submitted the ANDA to the U.S. FDA in February 2020, with a total R&D investment of approximately 7.6277 million yuan to date [1] - This approval represents the first time the company's formulation products have received U.S. FDA approval, indicating a deepening of the company's overseas business layout [1]