The US Food and Drug Administration (FDA) has accepted for filing with standard review the Jazz Pharmaceutical’s New Drug Application (NDA) seeking marketing approval for solriamfetol, an investigational medicine for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA). The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is December 20, 2018.
Read more: http://www.sleepreviewmag.com/2018/03/fda-accepts-jazz-pharmaceuticals-new-drug-application-solriamfetol-jzp-110-excessive-sleepiness-associated-narcolepsy-obstructive-sleep-apnea/