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Lumryz FDA Approval Status

Last updated by Judith Stewart, BPharm on Aug 25, 2022.

FDA Approved: No (Tentative Approval)
Brand name: Lumryz
Generic name: sodium oxybate
Previous Name: FT218
Company: Avadel Pharmaceuticals plc
Treatment for: Narcolepsy

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

  • On July 18, 2022, the U.S. Food and Drug Administration (FDA) granted tentative approval to Lumryz, also known as FT218. Tentative approval indicates that Lumryz has met all required quality, safety, and efficacy standards necessary for approval in the U.S. Final approval is pending disposition of U.S. Patent No. 8,731,963 (the “REMS patent”) which is listed in FDA’s Orange Book.
  • Final approval of Lumryz cannot be granted until the expiration or other disposition of U.S. Patent No. 8,731,963, which expires on June 17, 2023.

Development timeline for Lumryz

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  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

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