Epilepsy

• FDA label_change · 2026-03-20
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for carbamazepine from Torrent Pharmaceuticals Limited, resulting in labeling changes for the generi…

• FDA label_change · 2025-10-10
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal ODT (lamotrigine) from GlaxoSmithKline, likely updating labeling to reflect the orally …

• FDA label_change · 2025-06-14
  FDA Approved: VALTOCO — Supplemental Application (Neurelis, Inc)

  FDA approved a supplemental application for VALTOCO (diazepam) from Neurelis, Inc. The approval updates the product labeling.

• FDA label_change · 2025-02-25
  FDA Approved: LEVETIRACETAM — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for levetiracetam from Amneal Pharmaceuticals LLC, resulting in changes to the product labeling.

• FDA label_change · 2025-02-18
  FDA Approved: GABAPENTIN — Supplemental Application (American Health Packaging)

  FDA approved a supplemental application for Gabapentin (generic) submitted by American Health Packaging, indicating a labeling change for th…

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• FDA label_change · 2024-12-31
  FDA Approved: GABAPENTIN — Supplemental Application (Laurus Labs Limited)

  FDA approved a supplemental application for gabapentin filed by Laurus Labs Limited, indicating a post-approval labeling change or related u…

• FDA label_change · 2024-12-17
  FDA Approved: VIGABATRIN — Supplemental Application (Actavis Pharma, Inc.)

  FDA granted a supplemental approval for Vigabatrin by Actavis Pharma, Inc., updating the product under the ANDA process.

• FDA label_change · 2024-11-26
  FDA Approved: LEVETIRACETAM — Supplemental Application (ScieGen Pharmaceuticals, Inc.)

  FDA lists a supplemental application for levetiracetam by ScieGen Pharmaceuticals, Inc. under an approved ANDA; the specific change being re…

• FDA label_change · 2024-09-12
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved a supplemental application for Sabril (vigabatrin) by Lundbeck Pharmaceuticals LLC, resulting in a label change to reflect …

• FDA label_change · 2024-07-15
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for divalproex sodium submitted by Sun Pharmaceutical Industries, Inc. The action pertains to labeli…

• FDA label_change · 2024-06-14
  FDA Approved: LEVETIRACETAM — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Levetiracetam from Prasco Laboratories, resulting in changes to the drug's labeling.

• FDA label_change · 2024-05-15
  FDA Approved: CLOBAZAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for CLOBAZAM (clobazam) from Aurobindo Pharma Limited, updating the existing product through a suppl…

• FDA label_change · 2023-05-19
  FDA Approved: LAMOTRIGINE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for lamotrigine submitted by Actavis Pharma, Inc. The action pertains to updating or amending th…

• FDA label_change · 2022-12-14
  FDA Approved: CLONAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for clonazepam filed by Teva Pharmaceuticals USA, Inc.

• FDA label_change · 2022-08-04
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Advagen Pharma Limited)

  The FDA issued a supplemental approval for oxcarbazepine by Advagen Pharma Limited, resulting in changes to the product's labeling.

• FDA label_change · 2022-06-10
  FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Lamotrigine from Zydus Pharmaceuticals USA Inc., signaling a labeling change or addition to …

• FDA label_change · 2022-05-25
  FDA Approved: ZONISAMIDE — Supplemental Application (Viona Pharmaceuticals Inc)

  The FDA approved a supplemental application for Zonisamide from Viona Pharmaceuticals Inc, resulting in changes to the product label.

• FDA label_change · 2021-09-20
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for VIMPAT (lacosamide) filed by UCB, Inc. The approval results in a labeling change to the product …

• FDA label_change · 2021-06-30
  FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for TOPAMAX (topiramate) submitted by Janssen Pharmaceuticals; the snippet does not specify the exac…

• FDA label_change · 2021-02-05
  FDA Approved: ATIVAN — Supplemental Application (Bausch Health US LLC)

  The FDA approved a supplemental application for ATIVAN (lorazepam) submitted by Bausch Health US LLC, resulting in a labeling change for the…

• FDA label_change · 2021-02-05
  FDA Approved: KLONOPIN — Supplemental Application (H2-Pharma, LLC)

  The FDA approved a supplemental application for KLONOPIN (clonazepam) from H2-Pharma, LLC, resulting in changes to the product labeling.

• FDA label_change · 2020-12-09
  FDA Approved: SYMPAZAN — Supplemental Application (Aquestive Therapeutics)

  FDA approved a supplemental application for Sympazan (clobazam) from Aquestive Therapeutics, resulting in changes to the drug’s labeling/ind…

• FDA label_change · 2020-10-02
  FDA Approved: VIGABATRIN — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for Vigabatrin from Par Health USA, LLC, resulting in updated labeling for the product.

• FDA label_change · 2020-09-30
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for Keppra (levetiracetam) filed by UCB, Inc., resulting in labeling changes for the product.

• FDA label_change · 2020-08-31
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  FDA supplemental application approval for LAMICTAL ODT (lamotrigine) by GlaxoSmithKline, seeking changes to the product labeling.