Neurocrine To Refile Electronic NDA For Indiplon After Meeting With FDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Neurocrine to refile indiplon after meeting with FDA. Agency refuses to file application for the immediate-release formulation of Pfizer/Neurocrine’s insomnia agent due to difficulties with the electronic NDA. Firm also plans to reformat and refile its modified-release NDA to ensure consistency