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Avadel Pharma Says FDA Approves Pre-Launch Activities Importation Requests For LUMRYZ

RTTNews | 708 days ago

Avadel Pharma Says FDA Approves Pre-Launch Activities Importation Requests For LUMRYZ

(RTTNews) - Biopharmaceutical company Avadel Pharmaceuticals plc (AVDL) announced Wednesday that the U.S. Food and Drug Administration has approved its Pre-Launch Activities Importation Requests (PLAIR) for LUMRYZ.

Through its PLAIR, Avadel is authorized to import unapproved drug product into the U.S. ahead of anticipated final approval of the tentatively approved LUMRYZ NDA, to prepare for market launch.

By importing LUMRYZ into the U.S. before anticipated final approval, Avadel is able to further shorten the time to product availability following a final approval decision by the FDA.

LUMRYZ is an investigational formulation of sodium oxybate leveraging its proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.

Tags: AVDL

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