Dravet Syndrome

• CLINICAL_TRIALS approval · 2026-04-20
  Clinical Trial Update: Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol)

  The document notes that fenfluramine (Fintepla) has been approved for marketing for the treatment of Dravet Syndrome, including its use unde…

• CLINICAL_TRIALS approval · 2026-01-23
  Clinical Trial Update: Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome

  The document indicates that stiripentol has been approved for marketing and a plan to provide expanded-access treatment to patients with Dra…

• FDA approval · 2025-10-15
  FDA Approved: FINTEPLA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for Fintepla (fenfluramine) by UCB, Inc. The action updates the product’s labeling as part of th…

• FDA approval · 2025-04-08
  FDA Approved: FINTEPLA — Supplemental Application (UCB, Inc.)

  FDA supplemental application for Fintepla (fenfluramine) submitted by UCB, Inc.

• FDA approval · 2024-04-02
  FDA Approved: FINTEPLA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for Fintepla (fenfluramine) from UCB, Inc., authorizing additional regulatory approval for the d…

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• FDA approval · 2024-03-04
  FDA Approved: EPIDIOLEX — Supplemental Application (Jazz Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Epidiolex (cannabidiol) from Jazz Pharmaceuticals.

• FDA approval · 2023-12-11
  FDA Approved: FINTEPLA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for FINTEPLA (fenfluramine) filed by UCB, Inc., expanding/adjusting its labeling and indications.

• FDA approval · 2023-10-20
  FDA Approved: EPIDIOLEX — Supplemental Application (Jazz Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Epidiolex (cannabidiol) submitted by Jazz Pharmaceuticals, Inc. The action updates the labeling …

• FDA approval · 2023-09-14
  FDA Approved: FINTEPLA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for FINTEPLA (fenfluramine) from UCB, Inc.; the approval updates the drug's labeling and/or indicati…

• FDA approval · 2023-05-30
  FDA Approved: FINTEPLA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for FINTEPLA (fenfluramine) from UCB, Inc., indicating an approved update to its labeling/indication…

• FDA approval · 2022-06-15
  FDA Approved: FINTEPLA — Supplemental Application (UCB, Inc.)

  The FDA lists a supplemental application for Fintepla (fenfluramine) from UCB, Inc., indicating potential changes to labeling or indications…

• FDA approval · 2022-03-25
  FDA Approved: FINTEPLA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Fintepla (fenfluramine) submitted by UCB, Inc.

• FDA approval · 2021-09-30
  FDA Approved: EPIDIOLEX — Supplemental Application (Jazz Pharmaceuticals, Inc.)

  The FDA has approved a supplemental application for Epidiolex (cannabidiol) from Jazz Pharmaceuticals, Inc., indicating an update to its app…

• FDA approval · 2020-10-22
  FDA Approved: EPIDIOLEX — Supplemental Application (Jazz Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Epidiolex (cannabidiol) from Jazz Pharmaceuticals.

• FDA approval · 2020-07-31
  FDA Approved: EPIDIOLEX — Supplemental Application (Jazz Pharmaceuticals, Inc.)

  FDA approves a supplemental application for Epidiolex (cannabidiol) from Jazz Pharmaceuticals, expanding its labeling to reflect additional …

• FDA approval · 2020-06-25
  FDA Approved: FINTEPLA — Original Application (UCB, Inc.)

  FDA approved the original application for Fintepla (fenfluramine) by UCB, Inc., to treat convulsive seizures associated with Dravet syndrome…

• FDA approval · 2019-05-22
  FDA Approved: EPIDIOLEX — Supplemental Application (Jazz Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Epidiolex (cannabidiol) from Jazz Pharmaceuticals, updating the labeling to reflect the new …

• FDA approval · 2018-12-12
  FDA Approved: EPIDIOLEX — Supplemental Application (Jazz Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Epidiolex (cannabidiol) submitted by Jazz Pharmaceuticals, Inc. The action updates the produ…

• FDA approval · 2018-06-25
  FDA Approved: EPIDIOLEX — Original Application (Jazz Pharmaceuticals, Inc.)

  FDA approved Epidiolex (cannabidiol) under its original application for treating seizures in Lennox-Gastaut syndrome and Dravet syndrome. Th…