Partial-onset Seizures

• FDA approval · 2013-10-11
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  FDA has approved a supplemental application for Vimpat (lacosamide) submitted by UCB, Inc., updating the product labeling. This approval upd…

• FDA approval · 2013-09-25
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for VIMPAT (lacosamide) from UCB, Inc. This supplemental approval updates the existing NDA, typi…

• FDA approval · 2013-08-23
  FDA Approved: OXTELLAR XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)

  FDA approved a supplemental application for OXTELLAR XR (oxcarbazepine) from Supernus Pharmaceuticals, updating the product labeling.

• FDA approval · 2013-08-07
  FDA Approved: LEVETIRACETAM — Supplemental Application (WG Critical Care, LLC)

  The FDA approved a supplemental application for levetiracetam submitted by WG Critical Care, LLC.

• FDA approval · 2013-07-25
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Keppra (levetiracetam) submitted by UCB, Inc., authorizing changes to the drug's labeling.

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• FDA approval · 2013-07-25
  FDA Approved: KEPPRA XR — Supplemental Application (UCB, Inc.)

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

• FDA approval · 2013-06-30
  FDA Approved: FYCOMPA — Supplemental Application (Eisai Inc.)

  The FDA approved Eisai's supplemental application for FYCOMPA (perampanel), resulting in changes to the product labeling.

• FDA approval · 2013-06-14
  FDA Approved: OXTELLAR XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for OXTELLAR XR (oxcarbazepine) from Supernus Pharmaceuticals, indicating regulatory approval to…

• FDA approval · 2013-02-28
  FDA Approved: PREGABALIN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for pregabalin from Mylan Pharmaceuticals Inc. The approval confirms regulatory status of the generi…

• FDA approval · 2013-02-27
  FDA Approved: LEVETIRACETAM — Supplemental Application (QUAGEN PHARMACEUTICALS LLC)

  FDA approved a supplemental application for levetiracetam by Quagen Pharmaceuticals LLC.

• FDA approval · 2013-02-08
  FDA Approved: TRILEPTAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2013-02-08
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for VIMPAT (lacosamide) submitted by UCB, Inc., expanding/updating its labeling for epilepsy.

• FDA approval · 2013-02-08
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for VIMPAT (lacosamide) from UCB, Inc., resulting in a labeling update/expanded use for the anticonv…

• FDA approval · 2012-10-22
  FDA Approved: FYCOMPA — Original Application (Eisai Inc.)

  FDA approved FYCOMPA (perampanel) through Eisai's original NDA for treatment of seizures associated with epilepsy, beginning with partial-on…

• FDA approval · 2012-10-19
  FDA Approved: OXTELLAR XR — Original Application (Supernus Pharmaceuticals, Inc.)

  FDA approves OXTELLAR XR (oxcarbazepine) from Supernus Pharmaceuticals as an original application for an extended-release formulation to tre…

• FDA approval · 2012-09-17
  FDA Approved: OXCARBAZEPINE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's Original Application for generic oxcarbazepine (ANDA 202961).

• FDA approval · 2012-05-30
  FDA Approved: ZONISAMIDE — Supplemental Application (Viona Pharmaceuticals Inc)

  The FDA approved a supplemental application for zonisamide submitted by Viona Pharmaceuticals Inc under an ANDA. The action updates the labe…

• FDA approval · 2012-04-26
  FDA Approved: LEVETIRACETAM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for levetiracetam by Aurobindo Pharma Limited, approving this generic product under the ANDA.

• FDA approval · 2012-04-19
  FDA Approved: GABAPENTIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for gabapentin from Amneal Pharmaceuticals LLC, authorizing changes to the product under an exis…

• FDA approval · 2012-04-11
  FDA Approved: LEVETIRACETAM — Original Application (QUAGEN PHARMACEUTICALS LLC)

  FDA approved the original application for levetiracetam by Quagen Pharmaceuticals LLC, making a generic version of the antiepileptic availab…

• FDA approval · 2011-12-28
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's supplemental application for oxcarbazepine, allowing the marketing of a generic version of the antiepileptic drug.

• FDA approval · 2011-12-16
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for KEPPRA (levetiracetam) submitted by UCB, Inc., resulting in updated labeling for the drug. K…

• FDA approval · 2011-11-09
  FDA Approved: LEVETIRACETAM — Original Application (WG Critical Care, LLC)

  The FDA approved an original application for levetiracetam from WG Critical Care, LLC.

• FDA approval · 2011-10-13
  FDA Approved: LEVETIRACETAM — Original Application (Civica, Inc.)

  The FDA approved Civica, Inc.'s original application for a generic levetiracetam product. This approval provides a generic version of leveti…

• FDA approval · 2011-09-27
  FDA Approved: ZONISAMIDE — Supplemental Application (Viona Pharmaceuticals Inc)

  FDA approved a supplemental application for zonisamide submitted by Viona Pharmaceuticals, indicating approval of changes to the product.