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Avadel Pharmaceuticals (AVDL) FDA Events

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FDA Events for Avadel Pharmaceuticals (AVDL)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Avadel Pharmaceuticals (AVDL). Over the past two years, Avadel Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as LUMRYZ. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

LUMRYZ (sodium oxybate) - FDA Regulatory Timeline and Events

LUMRYZ (sodium oxybate) is a drug developed by Avadel Pharmaceuticals for the following indication: Extended-release sodium oxybate medication. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Avadel Pharmaceuticals FDA Events - Frequently Asked Questions

As of now, Avadel Pharmaceuticals (AVDL) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Avadel Pharmaceuticals (AVDL) has reported FDA regulatory activity for LUMRYZ (sodium oxybate).

The most recent FDA-related event for Avadel Pharmaceuticals occurred on June 30, 2025, involving LUMRYZ (sodium oxybate). The update was categorized as "Regulatory Update," with the company reporting: "Avadel Pharmaceuticals plc announced that, on Friday, June 27, 2025, the U.S. Court of Appeals for the District of Columbia Circuit (the "Appeals Court") affirmed a prior decision of the U.S. District Court for the District of Columbia (the "District Court") in favor of the U.S. Food and Drug Administration ("FDA") in a suit brought by Jazz Pharmaceuticals Inc."

Currently, Avadel Pharmaceuticals has one therapy (LUMRYZ (sodium oxybate)) targeting the following condition: Extended-release sodium oxybate medication.

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:AVDL) was last updated on 7/10/2025 by MarketBeat.com Staff
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