Epilepsy

• FDA label_change · 2015-08-28
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tegretol (carbamazepine) submitted by Novartis, resulting in labeling changes.

• FDA label_change · 2015-05-18
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal (lamotrigine) submitted by GlaxoSmithKline; the action updates the product labeling.

• FDA label_change · 2015-05-11
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for DIVALPROEX SODIUM (Divalproex Sodium) from Zydus Pharmaceuticals USA Inc., resulting in labeling…

• FDA label_change · 2014-11-08
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for divalproex sodium submitted by Sun Pharmaceutical Industries to update the product labeling.

• FDA label_change · 2014-09-26
  FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approves a supplemental application for lamotrigine from Zydus Pharmaceuticals USA Inc.

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• FDA label_change · 2014-06-20
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Depakote Sprinkles (divalproex sodium) from AbbVie, updating regulatory information for the …

• FDA label_change · 2014-01-16
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tegretol (carbamazepine) filed by Novartis, leading to changes to the product labeling.

• FDA label_change · 2013-12-20
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for LAMICTAL (lamotrigine) submitted by GlaxoSmithKline LLC. The supplemental approval resulted …

• FDA label_change · 2013-10-26
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved a supplemental application for SABRIL (vigabatrin) from Lundbeck Pharmaceuticals LLC, addressing changes to the product lab…

• FDA label_change · 2013-07-25
  FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for TOPAMAX (topiramate) filed by Janssen Pharmaceuticals, Inc. The approval updates the labelin…

• FDA label_change · 2013-06-14
  FDA Approved: DEPAKOTE — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Depakote (divalproex sodium) submitted by AbbVie, resulting in labeling changes for the prod…

• FDA label_change · 2013-03-06
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Tegretol (carbamazepine) filed by Novartis Pharmaceuticals Corporation. The supplemental act…

• FDA label_change · 2012-10-19
  FDA Approved: PRIMIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)

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

• FDA label_change · 2012-08-31
  FDA Approved: FELBAMATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for felbamate submitted by Mylan Pharmaceuticals Inc.

• FDA label_change · 2012-07-19
  FDA Approved: CLONAZEPAM — Supplemental Application (Accord Healthcare Inc.)

  The FDA approved a supplemental application for Accord Healthcare's clonazepam (generic clonazepam), resulting in updated labeling for the p…

• FDA label_change · 2012-02-28
  FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for lamotrigine by Zydus Pharmaceuticals USA Inc., resulting in updated labeling for the product.

• FDA label_change · 2011-11-29
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal ODT (lamotrigine) filed by GlaxoSmithKline, resulting in changes to the product labelin…

• FDA label_change · 2011-11-29
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal (lamotrigine) to update the product labeling.

• FDA label_change · 2011-08-29
  FDA Approved: GABAPENTIN — Supplemental Application (Granules Pharmaceuticals Inc)

  FDA approved a Gabapentin supplemental application from Granules Pharmaceuticals Inc.

• FDA label_change · 2011-07-15
  FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA page documents a supplemental application for TOPAMAX (topiramate) submitted by Janssen Pharmaceuticals, related to labeling changes…

• FDA label_change · 2011-04-25
  FDA Approved: ZARONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approves a supplemental application for Zarontin (ethosuximide) from Parke-Davis Div of Pfizer to update the product labeling.

• FDA label_change · 2010-10-11
  FDA Approved: TIAGABINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for tiagabine hydrochloride, resulting in updated labeling for the product marketed by Teva Phar…

• FDA label_change · 2010-09-10
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for divalproex sodium submitted by Mylan Pharmaceuticals Inc., resulting in a labeling update.

• FDA label_change · 2010-05-14
  FDA Approved: LAMOTRIGINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for lamotrigine from Sun Pharmaceutical Industries, resulting in labeling changes for the drug.

• FDA label_change · 2009-04-23
  FDA Approved: TRILEPTAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for TRILEPTAL (oxcarbazepine) submitted by Novartis Pharmaceuticals Corporation. The decision involv…