Epilepsy

• FDA approval · 2018-03-13
  FDA Approved: VIGABATRIN — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal's generic version of vigabatrin under an Original Application (ANDA 210155), enabling marketing of the drug for its esta…

• FDA approval · 2018-03-08
  FDA Approved: FOSPHENYTOIN SODIUM — Supplemental Application (West-Ward Pharmaceuticals Corp)

  FDA approved a supplemental application for fosphenytoin sodium submitted by West-Ward Pharmaceuticals Corp. The action updates labeling for…

• FDA approval · 2018-03-06
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Depakote ER (divalproex sodium) from AbbVie, authorizing changes to its labeling.

• FDA approval · 2018-01-29
  FDA Approved: LAMOTRIGINE KIT — Supplemental Application (OWP Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Lamotrigine Kit from OWP Pharmaceuticals, Inc.

• FDA approval · 2018-01-03
  FDA Approved: TROKENDI XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)

  FDA approved a supplemental application for TROKENDI XR (topiramate) from Supernus Pharmaceuticals, expanding the labeling of the extended-r…

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• FDA approval · 2017-12-29
  FDA Approved: LAMOTRIGINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approves Alembic Pharmaceuticals Limited's supplemental application for lamotrigine chewable dispersible, expanding the approved generic…

• FDA approval · 2017-12-27
  FDA Approved: GABAPENTIN — Supplemental Application (Creekwood Pharmaceuticals LLC)

  The FDA approved a supplemental application for gabapentin submitted by Creekwood Pharmaceuticals LLC. The approval covers changes to an alr…

• FDA approval · 2017-12-22
  FDA Approved: DILANTIN — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for DILANTIN (extended phenytoin sodium) from Viatris Specialty LLC.

• FDA approval · 2017-12-22
  FDA Approved: PHENYTOIN INFATABS — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Phenytoin Infatabs (phenytoin) submitted by Prasco Laboratories.

• FDA approval · 2017-11-24
  FDA Approved: TOPIRAMATE — Original Application (Zydus Lifesciences Limited)

  FDA approves the original generic application for Topiramate from Zydus Lifesciences Limited, enabling a generic version to reach the market…

• FDA approval · 2017-11-20
  FDA Approved: ACETAZOLAMIDE — Original Application (Strides Pharma Science Limited)

  FDA approved an original application for acetazolamide from Strides Pharma Science Limited, establishing a generic version of the drug. The …

• FDA approval · 2017-11-17
  FDA Approved: TRILEPTAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2017-11-03
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for VIMPAT (lacosamide) submitted by UCB, Inc., authorizing changes included in the supplemental sub…

• FDA approval · 2017-11-03
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for VIMPAT (lacosamide) filed by UCB, Inc.

• FDA approval · 2017-10-31
  FDA Approved: CEREBYX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

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

• FDA approval · 2017-10-25
  FDA Approved: LEVETIRACETAM — Original Application (Dr.Reddy's Laboratories Inc)

  FDA approved Dr. Reddy's Laboratories Inc. levetiracetam injection under an Original Application (ANDA 206880). This marks market approval o…

• FDA approval · 2017-10-24
  FDA Approved: KEPPRA XR — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for KEPPRA XR (levetiracetam) from UCB, expanding the product to an extended-release formulation…

• FDA approval · 2017-10-24
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for KEPPRA (levetiracetam) filed by UCB, Inc.

• FDA approval · 2017-10-24
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  FDA page indicating a supplemental application for KEPPRA (levetiracetam) by UCB, Inc. under NDA 021035.

• FDA approval · 2017-10-18
  FDA Approved: NEURONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for Neurontin (gabapentin) filed by Parke-Davis Div of Pfizer Inc. The approval concerns a modif…

• FDA approval · 2017-09-28
  FDA Approved: LEVETIRACETAM — Original Application (Hisun Pharmaceuticals USA, Inc.)

  FDA approved Hisun Pharmaceuticals USA, Inc.'s original application for a generic levetiracetam product.

• FDA approval · 2017-09-14
  FDA Approved: BRIVIACT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Briviact (brivaracetam) submitted by UCB, Inc.

• FDA approval · 2017-09-14
  FDA Approved: BRIVIACT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Briviact (brivaracetam) from UCB, authorizing changes to its labeling.

• FDA approval · 2017-09-13
  FDA Approved: APTIOM — Supplemental Application (Sumitomo Pharma America, Inc.)

  The FDA approved a supplemental application for APTIOM (eslicarbazepine acetate) submitted by Sumitomo Pharma America, Inc.

• FDA approval · 2017-08-15
  FDA Approved: DILANTIN-125 — Supplemental Application (Viatris Specialty LLC)

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