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Jazz Pharmaceuticals' narcolepsy drug application accepted for US FDA review

Jazz Pharmaceuticals Plc said the U.S. Food and Drug Administration will review its new drug application for solriamfetol to treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea.

Narcolepsy is a neurological disorder affecting control of sleep and wakefulness. It is characterized by excessive sleepiness and inability to regulate sleep-wake cycles normally. Obstructive sleep apnea is a disorder that causes breathing to repeatedly stop and start during sleep with excessive sleepiness as one of its major symptoms.

The target action date for the accepted application is Dec. 20.

Dublin-based Jazz Pharmaceuticals acquired the rights to develop and commercialize the drug from Aerial BioPharma LLC in 2014.