Epilepsy

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

  FDA approved a supplemental application for Lamictal XR (lamotrigine) submitted by GlaxoSmithKline LLC, resulting in changes to the product …

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

  The FDA approved a supplemental application for Lamictal (lamotrigine) from GlaxoSmithKline, updating the product labeling.

• FDA label_change · 2020-07-06
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for divalproex sodium from Zydus Pharmaceuticals USA Inc. to update the product labeling.

• FDA label_change · 2020-06-10
  FDA Approved: MYSOLINE — Supplemental Application (Bausch Health US, LLC)

  FDA approves a supplemental labeling application for Mysoline (primidone) from Bausch Health US, LLC. The action updates the drug's labeling…

• FDA label_change · 2020-01-29
  FDA Approved: LAMOTRIGINE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for Lamotrigine filed by Amneal Pharmaceuticals of New York LLC, indicating changes to its label…

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• FDA label_change · 2019-10-23
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for KEPPRA (levetiracetam) submitted by UCB, Inc., likely updating the product labeling. The act…

• FDA label_change · 2019-09-25
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal ODT (lamotrigine) submitted by GlaxoSmithKline LLC, updating the product labeling.

• FDA label_change · 2019-07-31
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approves a supplemental application for Sabril (vigabatrin) by Lundbeck Pharmaceuticals LLC, resulting in changes to the product's label…

• FDA label_change · 2018-12-27
  FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for TOPAMAX (topiramate) by Janssen Pharmaceuticals, Inc., resulting in labeling changes for the dru…

• FDA label_change · 2018-09-12
  FDA Approved: LEVETIRACETAM — Supplemental Application (Prasco Laboratories)

  The FDA granted a supplemental labeling/approval for LEVETIRACETAM through Prasco Laboratories under NDA 207958.

• FDA label_change · 2018-07-23
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal (lamotrigine) from GlaxoSmithKline, resulting in changes to the product labeling.

• FDA label_change · 2018-03-20
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Tegretol (carbamazepine) filed by Novartis Pharmaceuticals Corporation, updating the labelin…

• FDA label_change · 2017-10-31
  FDA Approved: DILANTIN-125 — Supplemental Application (Viatris Specialty LLC)

  Supplemental NDA application for DILANTIN-125 (phenytoin) by Viatris Specialty LLC, likely involving labeling changes or addition of a dosag…

• FDA label_change · 2017-10-05
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA approved a labeling supplement for Depakote Sprinkles (divalproex sodium) submitted by AbbVie.

• FDA label_change · 2017-10-05
  FDA Approved: DEPAKOTE — Supplemental Application (AbbVie Inc.)

  FDA approved AbbVie's supplemental application for Depakote (divalproex sodium), leading to changes to the product labeling.

• FDA label_change · 2017-04-05
  FDA Approved: TROKENDI XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)

  FDA approved a supplemental application for TROKENDI XR (topiramate) from Supernus Pharmaceuticals, Inc., leading to labeling updates for th…

• FDA label_change · 2017-03-23
  FDA Approved: TRILEPTAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for TRILEPTAL (oxcarbazepine) from Novartis Pharmaceuticals Corporation, resulting in a labeling…

• FDA label_change · 2016-11-04
  FDA Approved: CEREBYX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approves a supplemental application for Cerebyx (fosphenytoin sodium) from Pfizer Laboratories Div Pfizer Inc, updating labeling.

• FDA label_change · 2016-06-17
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tegretol (carbamazepine) to update the labeling language.

• FDA label_change · 2016-05-19
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (NorthStar Rx LLC)

  FDA supplemental application for divalproex sodium filed by NorthStar Rx LLC, likely involving labeling updates or other product changes. Th…

• FDA label_change · 2016-04-06
  FDA Approved: ZONEGRAN — Supplemental Application (Advanz Pharma (US) Corp.)

  FDA approved a supplemental application for ZONEGRAN (zonisamide) submitted by Advanz Pharma (US) Corp.

• FDA label_change · 2016-04-06
  FDA Approved: KEPPRA XR — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for Keppra XR (levetiracetam) from UCB, Inc., resulting in changes to the product labeling. The …

• FDA label_change · 2016-02-18
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote Sprinkles (divalproex sodium) from AbbVie, resulting in a labeling update for the produ…

• FDA label_change · 2016-01-25
  FDA Approved: DILANTIN-125 — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for DILANTIN-125 (phenytoin) from Viatris Specialty LLC, indicating a labeling update for this p…

• FDA label_change · 2015-09-18
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for Sabril (vigabatrin) submitted by Lundbeck Pharmaceuticals LLC.