Shanghai Pharmaceuticals (02607) Announces FDA Approval of Eslicarbazepine Acetate Tablets ANDA

Intelligent Finance APP, Shanghai Pharmaceuticals Holding Co.,Ltd (02607) announced recently that SPH Zhongxi Pharmaceutical Co., Ltd. (SPH Zhongxi), a subsidiary of Shanghai Pharmaceuticals Holding Co., Ltd., has received notification from the U.S. Food and Drug Administration (FDA) that its Abbreviated New Drug Application (ANDA) for Eslicarbazepine Acetate Tablets has been finally approved for marketing in the United States.

Eslicarbazepine Acetate Tablets are used to treat partial-onset seizures in patients aged 4 years and older. They were initially developed by Bial-Portela, Eisai, and Dainippon Sumitomo and launched in the U.S. in 2013. In January 2018, SPH Zhongxi submitted an ANDA application for this drug to the U.S. FDA, received tentative approval for four strengths in June 2020, and recently obtained final approval for marketing. As of the date of this announcement, the company has invested approximately RMB 15.9371 million in research and development expenses for this drug.