依折麦布阿托伐他汀钙片(Ⅰ)
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福元医药(601089.SH):依折麦布阿托伐他汀钙片(Ⅰ)获得药品注册证书
智通财经网· 2025-11-11 08:52
Core Viewpoint - The approval of Ezetimibe Atorvastatin Calcium Tablets (I) by the National Medical Products Administration marks a significant milestone for the company, allowing it to produce and market the drug in China for treating high cholesterol and homozygous familial hypercholesterolemia (HoFH) [1] Company Summary - The company, Fuyuan Pharmaceutical (601089.SH), has received the drug registration certificate for Ezetimibe Atorvastatin Calcium Tablets (I) from the National Medical Products Administration [1] - The drug contains 10mg of Ezetimibe and 10mg of Atorvastatin Calcium per tablet [1] - The drug was developed by Organon and was first approved by the FDA in May 2013 [1] - The approval for the drug's market entry in China was granted in September 2023 [1] Industry Summary - Ezetimibe Atorvastatin Calcium Tablets (I) are indicated for the treatment of high cholesterol and homozygous familial hypercholesterolemia (HoFH) [1]