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Has anyone else heard that the FDA has discontinued...?
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11-27-2012, 06:58 AM
Post: #2
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Yes your information is correct, here is an article on it:
A Novartis Drug Fails To Win F.D.A. Approval * Save * Share o Digg o Facebook o Newsvine o Permalink Article Tools Sponsored By Published: June 19, 2001 Novartis, Europe's third-biggest drug maker, failed to win United States approval for Zelnorm, a new treatment for irritable bowel syndrome. Regulators questioned the medicine's safety. Novartis, a Swiss drug maker, and its United States partner, Bristol-Myers Squibb, said they would keep fighting to win clearance for Zelnorm and are considering a formal appeal. Novartis's development head, Jörg Reinhardt, said the companies might also do additional studies. Zelnorm, known as Zelmac in Europe, is one of five major drug introductions Novartis planned this year, and analysts had considered the group of developmental medicines to be among the industry's best. The F.D.A.'s move is likely to delay any potential Zelnorm approval until at least 2003, investors said. The announcement came after the Swiss market had closed. American depository receipts of Novartis, based in Basel, fell $1.84, or 4.8 percent, to $36.20; shares of Bristol-Myers Squibb fell 44 cents, to $55.06. Novartis and Bristol-Myers had earlier pulled their European Union application for the treatment because European Union medical advisers questioned its effectiveness. Before, analysts had predicted Zelnorm would generate as much as $1 billion in annual sales. The F.D.A. refused to approve the drug because of concerns about the number of Zelnorm patients who underwent abdominal operations. In the company's studies, patients taking the drug had a higher rate of such procedures than did patients on a placebo. Still, the difference did not reach the statistical threshold that regulators generally use to determine that an occurrence is not because of chance. The agency mentioned concerns about the gall bladder surgeries only recently, and in last-minute conversations the F.D.A. rejected options like requiring marketing restrictions and warnings, Novartis said. Ads |
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Has anyone else heard that the FDA has discontinued...? - AMCgremlin - 11-27-2012, 06:49 AM
[] - Loving_Heart - 11-27-2012 06:58 AM
[] - jwjkrjstorm - 11-27-2012, 06:58 AM
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