Jazz's Sunosi gets milestone FDA approval

21 March 2019

Ireland-headquartered Jazz Pharmaceuticals (Nasdaq: JAZZ) has won US Food and Drug Administration (FDA) approval for Sunosi (solriamfetol) to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).

Sunosi becomes the first dual-acting dopamine and norepinephrine reuptake inhibitor to be approved in this indication and news of the approval saw shares in Jazz up by 1% in early trading on Thursday.

It is expected to be commercially available in the USA following the final scheduling decision by the US Drug Enforcement Administration.

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