FDA approves Shire's ADHD drug Vyvanse
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A new amphetamine-based drug to treat attention deficit hyperactivity disorder won federal approval Friday. It's harder to abuse than older stimulants, the manufacturer says.
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The U.S. Food and Drug Administration on Wednesday ordered all sleep disorder drugs to carry stronger warnings about their risks, including severe allergic reactions.
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Medtronic Inc., a maker of implantable medical devices, said Monday that it received Food and Drug Administration approval for its InSync Sentry implantable defibrillator system.
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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.
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WASHINGTON -- Drugs prescribed to treat attention deficit hyperactivity disorder will include guides to alert patients and parents of the risks of mental and heart problems, including sudden death.
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The U.S. House of Representatives  approved a bill on Wednesday aimed at strengthening Food and  Drug Administration drug safety oversight and raising  pharmaceutical industry fees that help speed product reviews.
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Fosrenol is Shireâs biggest new drug hope as it looks to reduce its reliance on hyperactivity drug Adderall XR, which accounts for about 40 percent of revenues but could face cheap, generic competition from 2006 or 2007.
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Pfizer Inc. said on Monday the US Food and Drug Administration has approved use of its Geodon schizophrenia drug to treat mania associated with bipolar disorder.
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Tablets of the drug etravirine were approved Friday by the Food and Drug Administration for the treatment of HIV infection in adults
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A second Food and Drug Administration advisory committee agreed that healthy children as young as 9 could be given the stimulant dextroamphetamine in an experiment, concurring with an ethics panel&#39;s recommendation last week.
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Two U.S. health agencies will conduct the largest-ever study of potential heart risks from medicines used to treat attention deficit hyperactivity disorder (ADHD), officials said on Monday.
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Two health agencies will conduct the largest-ever study of potential heart risks from medicines used to treat attention deficit hyperactivity disorder (ADHD), officials said on Monday.
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Drugs prescribed to treat attention deficit hyperactivity disorder will include guides to alert patients and parents of the risks of mental and heart problems, including sudden death.
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WASHINGTON - A second Food and Drug Adminis- tration advisory committee agreed that healthy children as young as 9 could be given the stimulant dextroamphetamine in an experiment, concurring with an ethics panel&#39;s recommendation last week.
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Drug maker Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co. said Friday that the Food and Drug Administration approved their antipsychotic drug Abilify for the treatment of acute bipolar mania.
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THE 64,000 dollar - correction, make that 500 million dollar â-uestion hanging over Shire Pharmaceuticals is whether the 5 per cent jump in the companyâs shares yesterday reflects relief that US regulators have finally approved its drug for
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Shire PLC, the UK maker of attention-deficit drug Adderall XR, agreed to buy New River Pharmaceuticals Inc. for $2.6 billion to gain full control of Vyvanse, a potential successor.