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FDA rejects Merck's suvorexant in insomnia; investors yawn

This article was originally published in Scrip

Executive Summary

It's unlikely investors will lose any sleep over the complete response letter (CRL) the FDA dished out to Merck on its experimental orexin receptor antagonist suvorexant (MK-4305), which the agency said needed more manufacturing studies on the 10mg dosage form before regulators would approve the drug as a treatment for insomnia – an unsurprising outcome.


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