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The agency plans to ask its advisers whether there is enough data to support a 10 milligram dose, according to draft questions posted online. ISI Group analyst Mark Schoenebaum called the FDA's review "tough." "The high dose is deemed unsafe, and the FDA wonders if there is enough data at the safer low dose to draw firm safety conclusions," Schoenebaum said in a note to investors. He says it could take Merck 18 months to resubmit its drug, if FDA requires another study of low-dose suvorexant. The potential impact on Merck's revenue is relatively small, since the drug is only expected to generate peak sales of $650 million by 2018. In January, the FDA required drugmakers of Ambien and similar sleeping pills to lower the dosage of their drugs, based on studies suggesting a link to drowsiness-related injuries. The agency cited research showing that the drugs remain in the bloodstream at levels high enough to interfere with driving. In midday trading, shares of Whitehouse Station, N.J.-based Merck slipped 52 cents to $45.48.
[Associated
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