Marc Hauser Dies: Celebrity Photographer For John Mellencamp’s ‘Scarecrow’ Was 66
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Merck announced that the company has received a Complete Response Letter from the U.S. Food and Drug Administration regarding the New Drug Application for suvorexant, Merck’s investigational medicine for the treatment of insomnia. In the Complete Response Letter, the FDA advised Merck that: the efficacy of suvorexant has been established at doses of 10 mg to 40 mg in elderly and non-elderly adult patients; 10 mg should be the starting dose for most patients, and must be available before suvorexant can be approved; 15 mg and 20 mg doses would be appropriate in patients in whom the 10 mg dose is well-tolerated but not effective; and, for patients taking concomitant moderate CYP3A4 inhibitors, a 5 mg dose would be necessary. In addition, the FDA determined that the safety data do not support the approval of suvorexant 30 mg and 40 mg. Based on initial review of the letter, Merck has determined that additional clinical studies of suvorexant 10 mg will not be necessary. However, manufacturing studies will be required to advance the 10 mg dosage form. Merck will discuss with the FDA whether additional studies will be required to support the 5 mg dose. View comments
# Rethinking Dale Carnegie: Why His Advice Falls Short
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