FDA accepts NDA for RedHill/IntelGenx oral thin film migraine drug
This article was originally published in Scrip
Executive Summary
The US FDA has granted a 10-month standard review to RedHill Biopharma for the Israeli biotech's new drug application (NDA) for RHB-103, an oral thin film formulation of rizatriptan benzoate, a 5-HT1 agonist, as a treatment for acute migraines – setting 3 February 2014 as the Prescription Drug User Fee Act (PDUFA) action date.