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FDA Accepts Jazz Pharma’s NDA for Review

NDA seeks marketing approval for solriamfetol, for the treatment of excessive sleepiness from narcolepsy or sleep apnea

The U.S. Food and Drug Administration (FDA) has accepted Jazz Pharmaceuticals’ New Drug Application (NDA) for standard review that seeks 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.   “We believe this medicine will provide a meaningful option for patients livin...

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