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Jul 15, 2013
 |  BC Week In Review  |  Clinical News  |  Regulatory

Suvorexant regulatory update

FDA issued a complete response letter for once-daily suvorexant from Merck to treat insomnia. In the letter, the agency requested manufacturing studies but no additional clinical studies for a 10 mg starting dose of suvorexant. Merck was seeking a label recommending use of 20-40 mg doses of the compound in...

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