TRENTON, N.J. — Drugmaker Merck & Co. said Monday that federal regulators have ruled they won't approve high doses of its experimental insomnia medication due to concerns about patient safety. However, the Food and Drug Administration indicated it would approve lower doses of the drug, suvorexant, after Merck does some new studies. Order Reprints Related News http://twitter.comLindaJ_onPharma More News Read more Business The agency's response likely will push back approval of suvorexant by at least several months. "We're in ongoing discussions with the FDA" to determine exactly what studies are needed to develop "a clear pathway forward," Merck spokesman Steve Cragle said in an...
↧