Lennox-gastaut Syndrome

• EMA approval · 2026-08-20
  EMA Authorised: Epidyolex (cannabidiol) — Jazz Pharmaceuticals Ireland Limited

  Authorised cannabidiol medicine Epidyolex for Lennox-Gastaut syndrome and other epilepsies with myoclonic features.

• EMA approval · 2026-04-24
  EMA Authorised: Epidyolex (cannabidiol) — Jazz Pharmaceuticals Ireland Limited

  Epidyolex (cannabidiol) has been authorised by the EMA for Lennox-Gastaut syndrome and myoclonic epilepsies, with Jazz Pharmaceuticals Irela…

• EMA approval · 2025-04-15
  EMA Authorised: Inovelon (rufinamide) — Eisai GmbH

  EMA authorised Inovelon (rufinamide) by Eisai GmbH for epilepsy, following a decision on 28 November 2023.

• FDA approval · 2025-04-15
  FDA Approved: RUFINAMIDE — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved Rufinamide from Novadoz Pharmaceuticals LLC through an Original Abbreviated New Drug Application.

• FDA approval · 2024-09-24
  FDA Approved: FELBAMATE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for felbamate from Amneal Pharmaceuticals of New York LLC, expanding the existing approval.

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• FDA approval · 2024-09-24
  FDA Approved: CLOBAZAM — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for CLOBAZAM (clobazam) from Ascend Laboratories, LLC.

• FDA approval · 2024-09-16
  FDA Approved: CLOBAZAM — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for CLOBAZAM (clobazam) from Amneal Pharmaceuticals NY LLC under the ANDA pathway.

• FDA approval · 2024-07-29
  FDA Approved: CLOBAZAM — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved a supplemental application for CLOBAZAM (clobazam) submitted by Amneal Pharmaceuticals NY LLC.

• FDA approval · 2024-07-15
  FDA Approved: CLOBAZAM — Supplemental Application (Novadoz Pharmaceuticals LLC)

  The FDA approved a supplemental application for CLOBAZAM filed by Novadoz Pharmaceuticals LLC.

• FDA approval · 2024-06-10
  FDA Approved: CLOBAZAM — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approves a supplemental application for CLOBAZAM (clobazam) submitted by Camber Pharmaceuticals, Inc. The action updates the regulatory …

• FDA approval · 2024-06-03
  FDA Approved: RUFINAMIDE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for Rufinamide submitted by Ascend Laboratories, LLC.

• FDA approval · 2024-05-24
  FDA Approved: CLOBAZAM — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for CLOBAZAM filed by Bionpharma Inc., confirming an additional approval for this clobazam produ…

• FDA approval · 2024-05-06
  FDA Approved: CLOBAZAM — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for CLOBAZAM (clobazam) submitted by Micro Labs Limited.

• FDA approval · 2024-03-12
  FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for ONFI (clonazepam) from Lundbeck Pharmaceuticals LLC.

• FDA approval · 2024-03-12
  FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for ONFI (clobazam) from Lundbeck Pharmaceuticals LLC.

• FDA approval · 2024-03-12
  FDA Approved: SYMPAZAN — Supplemental Application (Aquestive Therapeutics)

  FDA approved a supplemental application for Sympazan (clobazam) submitted by Aquestive Therapeutics.

• 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 · 2024-01-18
  FDA Approved: TOPIRAMATE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Topiramate from Zydus Lifesciences Limited. The action updates the product labeling and may expa…

• FDA approval · 2023-12-05
  FDA Approved: RUFINAMIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' generic Rufinamide as an original application for adjunctive treatment of seizures associated with Lenn…

• 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 · 2023-09-11
  FDA Approved: CLOBAZAM — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for CLOBAZAM (clobazam) from Upsher-Smith Laboratories, LLC.

• FDA approval · 2023-06-16
  FDA Approved: RUFINAMIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's original ANDA for a generic Rufinamide product, intended for seizures associated with Lennox-Gastaut…

• FDA approval · 2023-05-30
  FDA Approved: BANZEL — Supplemental Application (Eisai Inc.)

  FDA approved a supplemental application for BANZEL (rufinamide) submitted by Eisai Inc.

• FDA approval · 2023-05-22
  FDA Approved: CLOBAZAM — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for CLOBAZAM (clobazam) from Amneal Pharmaceuticals NY LLC, updating the approval of this generic pr…

• FDA approval · 2023-05-15
  FDA Approved: RUFINAMIDE — Original Application (Micro Labs Limited)

  FDA approved Rufinamide as an original ANDA submission from Micro Labs Limited.