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Jazz Pharmaceuticals (JAZZ) Receives New PDUFA Goal Date for Solriamfetol for Excessive Daytime Sleepiness

December 21, 2018 7:03 AM EST

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (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 March 20, 2019.

The FDA determined that an NDA submission made by Jazz during the course of... More