The FDA has approved a new combination drug from Merck for lowering cholesterol. The drug, which will carry the brand name of Liptruzet, is a combination of two previously approved cholesterol-lowering drugs, ezetimibe and atorvastatin. Merck said the new drug (pronounced “LIP-true-zett”) would be commercially available starting next week. Liptruzet will be available as a…

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A large observational study found no increased risk for cardiovascular events associated with azithromycin (Zithromax, Pfizer) in a general population of young and middle-age adults. In a paper published in the New England Journal of Medicine, Danish investigators report the results of a large national observational study comparing people who took azithromycin with matched controls…

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The FDA has issued a drug safety communication concerning tolvaptan (Samsca, Otsuka), a selective vasopression V2-receptor antagonist used in heart failure patients to treat clinically significant hypervolemic and euvolemic hyponatremia. The FDA said tolvaptan “should not be used for longer than 30 days and should not be used in patients with underlying liver disease because…

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Here are two small but important changes in the anticoagulation field: FDA approves new product for urgent reversal of anticoagulation. The FDA yesterday approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Unlike plasma, which is currently the only available method to…

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In recent years the FDA has come under increasing fire for approving drugs on the basis of surrogate endpoints without any evidence of greater clinical benefit. The most famous example of this is the diabetes drug rosiglitazone. Despite strong evidence demonstrating that it was effective at lower blood glucose levels — the surrogate endpoint — serious questions…

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Once again the controversial diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) will be the subject of a 2-day FDA hearing. According to a meeting announcement scheduled to be published in the Federal Register on April 15, the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet on June 5 and June 6 to  ”discuss the results…

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A new initiative involving a wide variety of stakeholders — the FDA, the American College of Cardiology, the Society of Thoracic Surgeons, industry, medical journals, and others — could lead to an enormous international cooperative effort to make device registries a standard part of the practice of cardiology. This will be a “huge step,” said David…

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For the second time the FDA has issued a complete response letter rejecting the new drug application (NDA) of oral treprostinil for the treatment of pulmonary arterial hypertension (PAH). The manufacturer of the drug, United Therapeutics, said in a press release that it planned to discuss the decision with the FDA. “We remain confident that oral treprostinil will…

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Automated external defibrillators (AEDs) will have a more difficult time getting on the market if a new FDA proposal is finalized. The agency today proposed a new rule that will require AED manufacturers to submit pre-market approval (PMA) applications. “Automated external defibrillators save lives,” said cardiologist William Maisel, deputy director of science and chief scientist…

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The U.S. FDA and Europe’s Committee for Medicinal Products for Human Use (CHMP) have taken opposite views of two important and controversial new cardiovascular drugs. Although earlier this month the FDA rejected — for the second time — an ACS indication for the oral anticoagulant rivaroxaban (Xarelto), CHMP announced today that it had adopted a positive opinion for the…

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