Zhi Tong Cai Jing·2025-11-10 09:44Core Viewpoint - Shanghai Pharmaceuticals has received final approval from the U.S. FDA for its abbreviated new drug application (ANDA) for Oxcarbazepine Tablets, marking a significant milestone for the company in the U.S. market [1] Company Summary - Shanghai Pharmaceuticals' subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd., has successfully obtained final approval for the ANDA of Oxcarbazepine Tablets [1] - The drug is indicated for the treatment of partial seizures in patients aged 4 years and older, originally developed by Bial-Portela, Eisai, and Dainippon Sumitomo [1] - The ANDA application was submitted to the U.S. FDA in January 2018, with temporary approval granted in June 2020 for four specifications, leading to the recent final approval [1] - The company has invested approximately RMB 15.9371 million in research and development for this drug [1]