(Reuters) - Regeneron Pharmaceuticals Inc said U.S. regulators have denied approval for it to expand use of its Arcalyst drug to prevent gout flares, asking that the company provide more clinical data. The rejection follows a unanimous vote against the drug's approval in early May by advisors to the U.S. Food and Drug Administration, with panel members expressing concern that the company had only done a 16-week study. ... via Health News Headlines - Yahoo! News Read More Here..
Tuesday 31 July 2012
FDA rejects expanded use of Regeneron drug for gout
(Reuters) - Regeneron Pharmaceuticals Inc said U.S. regulators have denied approval for it to expand use of its Arcalyst drug to prevent gout flares, asking that the company provide more clinical data. The rejection follows a unanimous vote against the drug's approval in early May by advisors to the U.S. Food and Drug Administration, with panel members expressing concern that the company had only done a 16-week study. ... via Health News Headlines - Yahoo! News Read More Here..
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