Lennox-gastaut Syndrome

• FDA approval · 2023-05-03
  FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved Janssen's supplemental application for Topamax (topiramate) and updated the product labeling.

• FDA approval · 2023-05-01
  FDA Approved: CLOBAZAM — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for CLOBAZAM (clobazam) submitted by Camber Pharmaceuticals, Inc. This action represents regulat…

• FDA approval · 2023-05-01
  FDA Approved: CLOBAZAM — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for CLOBAZAM (clobazam) from Bionpharma Inc., under ANDA208819.

• FDA approval · 2023-04-26
  FDA Approved: CLOBAZAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for CLOBAZAM by Aurobindo Pharma Limited, updating the regulatory status of this clobazam product.

• FDA approval · 2023-01-13
  FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)

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

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2023-01-13
  FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved a supplemental application for ONFI (clobazam) submitted by Lundbeck Pharmaceuticals LLC.

• FDA approval · 2023-01-13
  FDA Approved: SYMPAZAN — Supplemental Application (Aquestive Therapeutics)

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

• FDA approval · 2023-01-03
  FDA Approved: FINTEPLA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for FINTEPLA (fenfluramine) from UCB, Inc., expanding/ updating its labeling for the treatment of se…

• FDA approval · 2022-11-16
  FDA Approved: RUFINAMIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for Rufinamide (generic), expanding its regulatory status for the treatment…

• FDA approval · 2022-10-26
  FDA Approved: RUFINAMIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's Rufinamide as a generic drug via an Original Application (ANDA 216549).

• FDA approval · 2022-08-17
  FDA Approved: RUFINAMIDE — Original Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' generic Rufinamide (ANDA204964) for the treatment of seizures associated with Lennox-Gastaut syndrom…

• FDA approval · 2022-03-24
  FDA Approved: CLOBAZAM — Original Application (Aurobindo Pharma Limited)

  FDA approved an original ANDA for CLOBAZAM (clobazam) by Aurobindo Pharma Limited. It is a generic treatment for seizures associated with Le…

• FDA approval · 2021-12-03
  FDA Approved: CLOBAZAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for CLOBAZAM from Lupin Pharmaceuticals, Inc. to support an updated or expanded use of the product.

• FDA approval · 2021-10-20
  FDA Approved: CLOBAZAM — Supplemental Application (NorthStar RxLLC)

  The FDA approved a supplemental application for CLOBAZAM (clobazam) from NorthStar RxLLC under ANDA 209796, confirming its status as a gener…

• 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 · 2021-05-11
  FDA Approved: RUFINAMIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' generic Rufinamide (ANDA 204993) for the treatment of seizures associated with Lennox-Gastaut syndrome,…

• FDA approval · 2021-03-16
  FDA Approved: SYMPAZAN — Supplemental Application (Aquestive Therapeutics)

  FDA approved a supplemental application for Sympazan (clobazam) by Aquestive Therapeutics. The action updates the product labeling (and rela…

• FDA approval · 2021-02-23
  FDA Approved: RUFINAMIDE — Original Application (Ascend Laboratories, LLC)

  FDA approved Rufinamide under an original ANDA from Ascend Laboratories, LLC.

• FDA approval · 2021-02-05
  FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved a supplemental application for ONFI (clobazam) from Lundbeck Pharmaceuticals LLC, expanding its approved use for seizures i…

• FDA approval · 2021-02-05
  FDA Approved: SYMPAZAN — Supplemental Application (Aquestive Therapeutics)

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

• FDA approval · 2021-02-05
  FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for ONFI (clobazam) submitted by Lundbeck Pharmaceuticals LLC. The action represents an approval of …

• FDA approval · 2020-12-18
  FDA Approved: RUFINAMIDE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' generic Rufinamide via an ANDA for seizures associated with Lennox-Gastaut syndrome.

• 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 · 2020-08-11
  FDA Approved: RUFINAMIDE — Supplemental Application (Bionpharma Inc.)

  FDA approves a supplemental application for Rufinamide from Bionpharma Inc., updating the approved product under a supplemental submission.

• FDA approval · 2020-08-07
  FDA Approved: RUFINAMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Rufinamide from Hikma Pharmaceuticals USA Inc., updating the labeling for the product.