Epilepsy

• FDA approval · 2014-07-01
  FDA Approved: PHENYTOIN INFATABS — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Phenytoin Infatabs (phenytoin) from Prasco Laboratories, enabling continued marketing of thi…

• FDA approval · 2014-06-19
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  The FDA granted a supplemental approval for Depakote Sprinkles (divalproex sodium) from AbbVie under a supplemental application.

• FDA approval · 2014-06-19
  FDA Approved: DEPAKOTE — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote (divalproex sodium) submitted by AbbVie Inc. The approval indicates the agency has appr…

• FDA approval · 2014-06-12
  FDA Approved: CEREBYX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for Cerebyx (fosphenytoin sodium) from Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2014-06-12
  FDA Approved: LAMOTRIGINE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approves Alembic Pharmaceuticals' lamotrigine chewable dispersible as a generic lamotrigine product under an original ANDA.

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• FDA approval · 2014-06-10
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  FDA supplemental approval for Lamictal (lamotrigine) submitted by GlaxoSmithKline LLC, leading to updated labeling.

• FDA approval · 2014-06-10
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for LAMICTAL ODT (lamotrigine) from GlaxoSmithKline LLC.

• FDA approval · 2014-06-10
  FDA Approved: LAMICTAL XR — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for LAMICTAL XR (lamotrigine) submitted by GlaxoSmithKline LLC.

• FDA approval · 2014-06-09
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote Sprinkles (divalproex sodium) submitted by AbbVie. The action involves Depakote Sprinkl…

• FDA approval · 2014-06-09
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Depakote ER (divalproex sodium) submitted by AbbVie.

• FDA approval · 2014-06-09
  FDA Approved: CEREBYX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Cerebyx (fosphenytoin sodium) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2014-06-06
  FDA Approved: TRILEPTAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for TRILEPTAL (oxcarbazepine) by Novartis Pharmaceuticals Corporation, representing a regulatory upd…

• FDA approval · 2014-06-04
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  FDA Supplemental Application approval for VIMPAT (lacosamide) by UCB, Inc.

• FDA approval · 2014-06-02
  FDA Approved: DIVALPROEX SODIUM — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's original ANDA for divalproex sodium, enabling a generic version of the drug.

• FDA approval · 2014-05-08
  FDA Approved: TRILEPTAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2014-05-08
  FDA Approved: TRILEPTAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Trileptal (oxcarbazepine) submitted by Novartis Pharmaceuticals Corporation, resulting in ch…

• FDA approval · 2014-04-24
  FDA Approved: LAMOTRIGINE EXTENDED RELEASE — Supplemental Application (Par Health USA, LLC)

  FDA approves a supplemental abbreviated new drug application for Lamotrigine Extended Release from Par Health USA, LLC.

• FDA approval · 2014-04-18
  FDA Approved: TROKENDI XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for TROKENDI XR (topiramate extended-release) from Supernus Pharmaceuticals, Inc. The action may…

• FDA approval · 2014-04-17
  FDA Approved: PHENYTOIN — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved an original application for PHENYTOIN (generic phenytoin) by Sun Pharmaceutical Industries.

• FDA approval · 2014-04-03
  FDA Approved: DILANTIN-125 — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for DILANTIN-125 (phenytoin) from Viatris Specialty LLC.

• FDA approval · 2014-03-20
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for divalproex sodium submitted by Sun Pharmaceutical Industries.

• FDA approval · 2014-03-18
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for DIVALPROEX SODIUM submitted by Bionpharma Inc.

• FDA approval · 2014-03-18
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Apotex Corp.)

  The FDA approved Apotex Corp.'s supplemental application for carbamazepine, a generic anticonvulsant. This action updates the approval statu…

• FDA approval · 2014-03-11
  FDA Approved: TOPIRAMATE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved the original application for Topiramate from Upsher-Smith Laboratories, LLC.

• FDA approval · 2014-03-10
  FDA Approved: EPITOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for EPITOL (carbamazepine) from Teva Pharmaceuticals USA, Inc.