BRIEF — Sleepiness drug label expanded to include children

29 October 2018

Shares in Jazz Pharmaceuticals were up 2% after two hours trading on Monday amid news of an expanded approval for Xyrem (sodium oxybate) oral solution in the USA.

The US Food and Drug Administration (FDA) approved the supplemental new drug application from the Ireland-based drugmaker to include an indication to treat cataplexy or excessive daytime sleepiness in pediatric patients with narcolepsy, adding to the adult approval.

This makes Xyrem the first medicine approved to treat cataplexy or excessive daytime sleepiness in children and adolescents with narcolepsy ages seven and older.

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