Epilepsy

• FDA approval · 2015-04-16
  FDA Approved: PHENYTOIN INFATABS — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Phenytoin Infatabs (phenytoin) from Prasco Laboratories.

• FDA approval · 2015-04-15
  FDA Approved: FOSPHENYTOIN SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for fosphenytoin sodium from Amneal Pharmaceuticals LLC (ANDA 078476).

• FDA approval · 2015-04-15
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

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

• FDA approval · 2015-04-14
  FDA Approved: TRILEPTAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2015-04-06
  FDA Approved: DIAZEPAM — Supplemental Application (Hospira, Inc.)

  The FDA approved Hospira, Inc.'s supplemental application for diazepam (generic) under the ANDA.

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• FDA approval · 2015-03-31
  FDA Approved: GABAPENTIN — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  FDA approved a supplemental application for gabapentin filed by Quallent Pharmaceuticals Health LLC under ANDA200651.

• FDA approval · 2015-03-24
  FDA Approved: LAMICTAL XR — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2015-03-24
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for LAMICTAL ODT (lamotrigine) from GlaxoSmithKline LLC. The action indicates an approved change to …

• FDA approval · 2015-03-16
  FDA Approved: GABAPENTIN — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Gabapentin from Actavis Pharma, Inc., resulting in approval of a generic gabapentin product.

• FDA approval · 2015-03-13
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental NDA for Depakote Sprinkles (divalproex sodium) from AbbVie, updating labeling and/or indications for the Spr…

• FDA approval · 2015-03-10
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for Keppra (levetiracetam) filed by UCB, Inc., updating the labeling.

• FDA approval · 2015-03-10
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for KEPPRA (levetiracetam) from UCB, Inc.

• FDA approval · 2015-03-10
  FDA Approved: KEPPRA XR — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for KEPPRA XR (levetiracetam) from UCB, authorizing an extended-release formulation for use in epile…

• FDA approval · 2015-03-10
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for Keppra (levetiracetam) submitted by UCB, Inc., reflecting an update to the product labeling.

• FDA approval · 2015-03-09
  FDA Approved: DIAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a Teva supplemental application for Diazepam, resulting in an approved labeling change under ANDA 071321.

• FDA approval · 2015-03-05
  FDA Approved: GABAPENTIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Gabapentin from Aurobindo Pharma Limited, enabling the generic product's continued marketing und…

• FDA approval · 2015-02-25
  FDA Approved: LEVETIRACETAM — Original Application (Apotex Corp.)

  FDA approves Apotex Corp's generic levetiracetam for the treatment of seizures associated with epilepsy under an Original Application. This …

• FDA approval · 2015-02-18
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Apotex Corp.)

  The FDA approved a supplemental application for carbamazepine filed by Apotex Corp., indicating an approved modification to the generic prod…

• FDA approval · 2015-02-18
  FDA Approved: LEVETIRACETAM — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for LEVETIRACETAM from Bionpharma Inc., resulting in updated labeling for the product.

• FDA approval · 2015-02-18
  FDA Approved: LAMOTRIGINE — Supplemental Application (Advagen Pharma Limited)

  FDA approved a supplemental application for lamotrigine by Advagen Pharma Limited (ANDA 078625).

• FDA approval · 2015-02-04
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical's supplemental application for Oxcarbazepine. This action updates the drug's labeling.

• FDA approval · 2015-02-04
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for oxcarbazepine submitted by Amneal Pharmaceuticals LLC, expanding the regulatory authorizatio…

• FDA approval · 2015-02-03
  FDA Approved: KLONOPIN — Supplemental Application (H2-Pharma, LLC)

  The FDA approved a supplemental application for KLONOPIN (clonazepam) filed by H2-Pharma, LLC.

• FDA approval · 2015-02-03
  FDA Approved: LEVETIRACETAM — Supplemental Application (WG Critical Care, LLC)

  The FDA approved a supplemental application for levetiracetam from WG Critical Care, LLC, indicating a labeling/indication change for the dr…

• FDA approval · 2015-01-24
  FDA Approved: LEVETIRACETAM — Supplemental Application (SOHM, Inc.)

  FDA approved a supplemental application for Levetiracetam from SOHM, Inc. under an ANDA.