Neurocrine To Refile Electronic NDA For Indiplon After Meeting With FDA
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA refuses to file application for the immediate-release formulation of Pfizer/Neurocrine's insomnia agent "due to difficulties encountered in navigating the electronic NDA," Neurocrine says. An NDA for the modified-release formulation is under review and will require "modest" changes, company says.