上海医药(02607.HK):醋酸艾司利卡西平片获得美国FDA批准文号
Core Viewpoint - Shanghai Pharmaceuticals has received final approval from the U.S. FDA for its abbreviated new drug application (ANDA) for Acetate Eslicarbazepine Tablets, which are used to treat partial seizures in patients aged 4 and above [1] Company Summary - The product was initially developed by Bial-Portela, Eisai, and Dainippon Sumitomo and was first launched in the U.S. in 2013 [1] - Shanghai Pharmaceuticals submitted the ANDA to the U.S. FDA in January 2018 and received temporary approval for four specifications in June 2020 [1] - The company has invested approximately RMB 15.9371 million in research and development for this product as of the announcement date [1]