Merck Silence On OTC Singulair Speaks Volumes On Switch Outlook
Merck’s silence on an OTC version of Singulair is a sign of the relatively “quiet” 2015 switch market despite the call for novel switches, particularly to treat chronic conditions, from FDA’s Nonprescription Drug Safe Use Regulatory Expansion Initiative.
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A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
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Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
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A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.