FDA Tells Merck More Arcoxia Data Needed
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The Food and Drug Administration told Merck &amp; Co. that the company needs to supply more data for its Arcoxia pain treatment to gain approval, the pharmaceutical company said Friday.
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Merck &amp; Co., which withdrew the Vioxx painkiller last month because of a heart risk, said yesterday that US regulators have asked for more safety data before they will approve the medicine&#39;s successor, Arcoxia.
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Most analysts and doctors had not expected the FDA to give Arcoxia a green light now because Merck pulled Vioxx from the market last month after a study showed it doubled patients risk of heart attacks and strokes.
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Two years after the withdrawal of the painkiller Vioxx, federal health regulators still lack the resources necessary to track the safety of new drugs and respond quickly to any problems that might crop up, a panel of experts said Friday.
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Drug giant Merck says the Food and Drug Administration wants more information, but is prepared to approve the company&#39;s successor drug to recalled pain reliever Vioxx.
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The potential heart risks of GlaxoSmithKline Plc's diabetes drug Avandia are still not clear, the head of the U.S. Food and Drug Administration told lawmakers who questioned the agency's oversight of the widely used pill on Wednesday.
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The U.S. Food and Drug   Administration needs more staff, funding and power over the   drug industry to better police the safety of medicines after   they reach the market, an Institute of Medicine panel said on   Friday.
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The global pharmaceutical industry unveiled plans on Thursday to publish more data about trials of medicines in a bid to reassure patients following recent alarms over drug safety.
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NEW YORK, December 24  - The Food &amp; Drug Administration (FDA) announced yesterday that it planned to examine the various studies that link the usage of several painkillers with heightened cardiovascular risks, while recommending that
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U.S. health officials said on Friday  they would review whether to take regulatory action over Merck  & Co Inc and Schering-Plough's cholesterol medicine Vytorin  following the drug's failure to work better than a generic drug  in a study of plaque build-up in neck arteries.
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U.S. health officials said on Friday they would review whether to take regulatory action over Merck & Co Inc  and Schering-Plough's  cholesterol medicine Vytorin following the drug's failure to work better than a generic drug in a study of plaque build-up in neck arteries.
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WASHINGTON -- After months of heightened concerns about the safety and effectiveness of Vioxx and similar best-selling painkillers, and intense criticism of how the Food and Drug Administration has handled them, the agency will launch critical meetings beginning tomorrow on what to do next.
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ROCKVILLE, Md.  - The U.S. Food and Drug  Administration on Friday asked an outside group to review the  way it monitors safety risks associated with medicines already  on the market, such as Merck & Co. Inc.'s withdrawn painkiller  Vioxx.
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Merck & Co. Inc.'s painkiller Arcoxia offers a "marginal" advantage in gastrointestinal safety but seems "worse than" other pain drugs in terms of deaths and serious cardiovascular problems, U.S. regulatory staff said in documents released on Friday.
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Anonymous messages posted on a Web site raise questions about the handling of data on a Merck &amp; Co Inc  and Schering-Plough Corp  cholesterol drug, two House of Representatives Democrats said on Monday.
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U.S. health officials said on Friday  they would review whether to take regulatory action over Merck  & Co Inc  and Schering-Plough's  cholesterol  medicine Vytorin following the drug's failure to work better  than a generic drug in a study of plaque build-up in neck  arteries.
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FDA has launched a review of its records of the August 2001 withdrawal from the market of Bayer&#39;s statin Baycol in light of allegations made last week that the pharmaceutical company was aware of the risks associated with the drug but failed to inform FDA