FDA extends PDUFA date for solriamfetol as a treatment to improve wakefulness and reduce excessive daytime sleepiness .- Jazz Pharma
Jazz Pharmaceuticals plc announced that the FDA has extended the review period for its 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 20 March 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.
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