A first drug in a new class of insomnia treatments was rejected by the Food and Drug Administration (FDA) because the agency said safety data didn’t support approval of the treatment at the dosing proposed. The drug, called suvorexant, made by Merck & Co., was under review by the FDA in both 30- and 40-milligram doses. The FDA advised Merck that suvorexant was effective at doses as low as 10 milligrams up to 40 milligrams, with 10 milligrams seen as the starting point. As a result, the FDA advised that Merck seek approval for the lowest dosage before it grants ... Read More
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