The US Food and Drug Administration (FDA) has extended the review period for Jazz Pharmaceuticals plc’s new drug application (NDA) for solriamfetol as a treatment to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA). The updated Prescription Drug User Fee Act (PDUFA) goal date is now March 20, 2019.
The FDA determined that an NDA submission made by Jazz during the course of discussions regarding draft labeling for solriamfetol constitutes a major amendment to the NDA, resulting in a three-month extension of the PDUFA goal date to provide time for a full review of the submission.
“We appreciate the opportunity to work with the FDA to complete the review process as soon as possible,” says Jed Black, MD, senior vice president, Sleep and CNS Medicine at Jazz Pharmaceuticals and adjunct professor, Stanford University Medical Center, Stanford Center for Sleep Sciences and Medicine, in a release. “We are committed to addressing unmet needs in sleep medicine and look forward to offering solriamfetol as a meaningful treatment option for patients living with excessive daytime sleepiness associated with narcolepsy or OSA.”
from Sleep Review http://www.sleepreviewmag.com/2018/12/jazz-new-drug-application-review-extended/