Cleviprex, an injected drug to treat high blood pressure, produced by the New Jersey Based Medicines Co. of Parsippany, has been approved by the U.S. Food and Drug Administration.
Cleviprex is the latest-generation IV dihydropyridine calcium channel blocker. The first-cycle U.S. approval of Cleviprex was based on six Phase III trials involving 1,406 patients medical and surgical patients treated with Cleviprex. All Phase III trials met all of their primary endpoints.
Cleviprex doesn't accumulate in the body since it is metabolized in the tissues and blood, not the kidneys or liver. The most common adverse reactions seen with Cleviprex are headache, nausea and vomiting.
Poorly controlled blood pressure can be a life-threatening condition that can cause permanent damage to the brain, heart, kidneys and blood vessels. It can occur in a broad range of patients and is frequently found in patients undergoing surgery and in patients present in the emergency department of a hospital.
The Medicines Company is focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace.
John Kelley, President and Chief Operating Officer of The Medicines Company quotes: "Cleviprex presents physicians with a valuable option to effectively treat a broad array of patients who need rapid and precise blood pressure control."
Clive Meanwell, Chief Executive Officer of The Medicines Company states that with the approval of Cleviprex, The Medicines Company will continue to deliver on its vision of advancing innovation in the critical care settings.
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