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FDA Issues Approvable Letter for Eszopiclone

Posted by jerrympls on March 3, 2004, at 20:42:15

After conducting 24 clinical trials involving more than 2,700 adults and elderly patients, Sepracor, Inc. has been sent an "approvable" letter by the US Food and Drug Administration (FDA) for a new hypnotic medication, Estorra (eszopiclone). When final approval is achieved, Estorra will be available by prescription for the treatment of insomnia. According to a report by Sepracor, there will not be limits on the duration of use for this medication.



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poster:jerrympls thread:319921
URL: http://www.dr-bob.org/babble/20040228/msgs/319921.html