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December 23, 2019Conjupri Approved for Hypertension
December 23, 2019 – The U.S. FDA has approved Conjupri® (levamlodipine) tablets, manufactured by CSPC Pharmaceutical Group, for use either alone or in combination with other antihypertensive agents to treat hypertension and lower blood pressure, which can reduce the risk of fatal and nonfatal cardiovascular events.
Better known as high blood pressure, hypertension affects approximately 32% of adults in the United States, as well as up to 4% of children. The condition raises an individual’s risk of heart attack, stroke, and other cardiovascular events, and can damage various organs including the heart, brain, kidneys, and eyes. However, high blood pressure can be controlled through lifestyle changes and medication to reduce the risk of damage and serious complications.
Conjupri’s active ingredient, levamlodipine, is a derivative of amlodipine, an FDA-approved medication indicated to treat hypertension and coronary artery disease. Levamlodipine has been marketed in China since 2003 under the name Xuanning, and FDA approval for Conjupri is based in part on safety and efficacy data demonstrated in China. In addition, the agency considered data that demonstrates levamlodipine has fewer adverse events compared to amlodipine. For adults, the recommended dose ranges from 1.25mg to 5mg per day depending on individual patient factors. Recommended dosing for pediatric patients is 1.25mg to 2.5mg once daily.
Launch and pricing plans for Conjupri have not been announced.