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FDA rejects Merck insomnia drug, seeks lower-dose

Started by riky, July 02, 2013, 09:00:23 AM

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riky

FDA rejects Merck insomnia drug, seeks lower-dose

(Reuters) - U.S. health regulators have rejected Merck & Co's new insomnia drug application but opened the door to approving a lower-dose version of the medication, the company said on Monday. Merck said it received a complete response letter from the U.S. Food and Drug Administration saying that the agency could consider a 10 milligram starting dose of suvorexant for most patients, but that the company would have to have that dosage ready before it could be approved. ...

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