Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Changzhou Pharmaceutical Factory, received final approval from the U.S. FDA for the abbreviated new drug application (ANDA) for Ticagrelor tablets, which are used to reduce the incidence of thrombotic cardiovascular events in patients with acute coronary syndrome [1] Company Summary - The ANDA for Ticagrelor tablets was submitted to the U.S. FDA in May 2021 and has now been approved for market launch [1] - The company has invested approximately RMB 9.6713 million in research and development for this drug as of the date of the announcement [1] Industry Summary - Ticagrelor is indicated for patients with acute coronary syndrome, including those undergoing medical therapy and percutaneous coronary intervention, to lower the risk of thrombotic cardiovascular events [1] - The original drug was developed by AstraZeneca and was launched in the U.S. in 2011 [1]
上海医药(601607.SH):替格瑞洛片获得美国FDA批准文号