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Lumryz FDA Approval History

Last updated by Judith Stewart, BPharm on May 2, 2023.

FDA Approved: Yes (First approved May 1, 2023)
Brand name: Lumryz
Generic name: sodium oxybate
Dosage form: Granules for Extended-Release Oral Suspension
Company: Avadel Pharmaceuticals plc
Treatment for: Narcolepsy

Lumryz (sodium oxybate) is a once-nightly formulation of the approved central nervous system depressant sodium oxybate indicated for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.

Development timeline for Lumryz

May  1, 2023Approval FDA Approves Lumryz (sodium oxybate) for Cataplexy or Excessive Daytime Sleepiness in Adults with Narcolepsy
Mar  2, 2023Avadel Pharmaceuticals Requests Final FDA Approval for Lumryz (sodium oxybate) Extended-Release Oral Suspension
Jul 19, 2022Avadel Pharmaceuticals Announces Tentative Approval of Lumryz (sodium oxybate) Extended-Release Oral Suspension
Mar 11, 2022Avadel Announces New Positive Data for Once-at-Bedtime FT218 for Narcolepsy and Once-Nightly Dosing Preference Among Patients and Clinicians
Mar  1, 2021Avadel Pharmaceuticals Announces FDA Acceptance of New Drug Application for FT218 in Adults with Narcolepsy for the Treatment of Excessive Daytime Sleepiness and Cataplexy

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.