FDA OKs Over-The-Counter Defibrillator Sales
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The U.S. Food and Drug Administration on Thursday approved a medical device maker's request to sell at-home heart defibrillators without a prescription.
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FDA advisory panel gives the nod to its heart drug.
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The Pittsburg-based generic drugmaker said the Food and Drug Administration has approved its metoprolol tartrate and hydrochlorothiazide tablets, which will compete with the Loppressor HCT tablets made by the Switzerland-based Novartis.
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WASHINGTON -- The Food and Drug Administration plans to revamp how it handles safety issues with the stents, pacemakers, implantable defibrillators and other medical devices it regulates.
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WASHINGTON - The Food and Drug Administration yesterday gained broad new powers to ensure the safety of prescription drugs used by millions of Americans under a bill signed by President Bush.
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US anti-monopoly officials approve Johnson & Johnson's purchase of Pfizer's over-the-counter medicines.
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A Concord company is recalling 10,000 automated external defibrillators because they didn't work properly and, at times, turned themselves on. Access CardioSystems Inc. is recalling defibrillators that are used by fire departments and hospitals around the nation. Some of the devices are currently in use, while others remained at distributors awaiting shipment. &quot;They're no longer in business. They can't correct ...
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The U.S. Food and Drug  Administration on Monday issued a warning to patients taking  the painkiller naproxen after a government study showed the  over-the-counter medicine can cause an increased risk of heart  problems.
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Federal advisers today and tomorrow will consider whether the Food and Drug Administration should approve Merck &amp; Co.'s bid to make Mevacor the first of a class of hot-selling cholesterol-lowering drugs called statins to be sold over the counter.
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Shares of Boston Scientific (BSX:NYSE - news - research) rose Monday following the announcement that the Food and Drug Administration had approved its product to reduce the risk of a heart attack following heart bypass surgery.
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If a recently reported case is a reliable indicator, the over-the-counter medication pseudoephedrine can cause a heart attack -- even in healthy young adults.
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In recent years, automated external defibrillators (AEDs) have entered public spaces to treat someone suffering what bystanders may assume is a heart attack: Clutching the chest, the victim collapses, unconscious.
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The government on Wednesday approved over-the-counter sales of the fat-blocking diet pill orlistat, allowing direct sales for the first time of a version of a diet drug that had been available only by prescription.
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BETHESDA, Md.  - Drug maker Merck & Co. Inc.   urged U.S. advisers on Thursday to approve the first  over-the-counter sales of a cholesterol-lowering pill, but  regulators questioned if consumers would use it properly.
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The US Food and Drug Administration has given clearance to Boston Scientific Corp. to market its Peripheral Cutting Balloon microsurgical dilation device in the United States.
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Sales of over-the-counter drugs taken to treat the flu may help the government learn more quickly about local outbreaks.
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The first implantable treatment to prevent sleep apnea has received approval from U.S. regulators, the company that developed the procedure said Tuesday.