FDA Novartis Late with Dog Painkiller Reports
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Novartis AG failed to give the  government prompt, accurate reports about deaths of dogs  treated with a painkiller in the same class of medicines now  linked to heart problems in humans, U.S. regulators have  charged in a letter.
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U.S. regulators have asked for more data  on Novartis AG's  diabetes drug Galvus, possibly  delaying approval of the potential blockbuster by a year, which  dented its shares while boosting its main rival's.
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Swiss pharmaceutical giant Novartis AG said Tuesday it is temporarily withdrawing an application for European Union approval of its painkiller Prexige, but added that it will present new data this week to prove the safety and effectiveness of the drug.
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Two studies offer more evidence about   the dangers of some painkillers, adding kidney problems to   heart concerns already raised with the drug once sold as Vioxx,   researchers said on Tuesday.
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Novartis&#39; pain killer Prexige did not raise the rate of serious heart issues and led to fewer ulcer problems compared to normal anti-inflammatory drugs, results of a study of over 18,000 patients showed.
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NIH researchers uncovered the potential problem with naproxen, an Aleve ingredient, last Friday during a quick review of data from a large, ongoing Alzheimer's disease study.
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Novartis AG failed to give the government prompt, accurate reports about deaths of dogs treated with a painkiller in the same class of medicines now linked to heart problems in humans, US regulators have charged in a letter.
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Authorities and pet owners are beginning to raise serious questions about the safety and effectiveness of animal medicines, mirroring worries over human drugs like the painkiller Vioxx.
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BEIJING, Dec. 24 -- FDA has recommended on Thursday that doctors and users are cautious to use the controversial painkillers -- Pfizer Inc.
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Less than a week after two sets of new data raised questions about the cardiovascular safety of two widely used painkillers, the Pfizer Inc.
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Merck &amp; Co. said the US Food and Drug Administration has requested additional safety and efficacy information on its Vioxx successor, Arcoxia, before it considers granting US approval for the drug.
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Saying there is evidence the Food and Drug Administration is suppressing scientific reports and maintaining too cozy a relationship with drug companies it regulates, US Sen. Charles Grassley of Iowa today will hold a hearing on the drug Vioxx.
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New reports accuse another drug company of being too slow to pull a dangerous medication from the market and question the ability of the US federal Food and Drug Administration to protect Americans from such risks.
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The US Food and Drug Administration is recommending physicians limit prescriptions for popular painkillers known as Cox-2 inhibitors after recent studies suggested they may increase the risk of heart attacks and strokes.
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Clinical trial results show significant   benefits for patients with relapsing multiple sclerosis treated   with Novartis's experimental FTY720 medicine, the company said   late on Wednesday.
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The U.S. Food and Drug Administration has ordered 20 companies, including Novartis AG's Sandoz unit, to stop marketing a number of unapproved drugs used to fight headaches, the agency said on Thursday.
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On the same day that Merck &amp; Co. Inc. announced its receipt of an approvable letter from the Food and Drug Administration for use of Arcoxia (etoricoxib) in several inflammatory conditions, the company said