Seizure Disorders

• FDA approval · 2016-05-02
  FDA Approved: DIAZEPAM INTENSOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Diazepam Intensol from Hikma Pharmaceuticals USA Inc., confirming changes to the approved pr…

• FDA approval · 2016-04-18
  FDA Approved: LORAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Lorazepam from Hikma Pharmaceuticals USA Inc., indicating an approved update to the drug's l…

• FDA approval · 2016-03-24
  FDA Approved: DIAZEPAM — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application to Chartwell RX, LLC for diazepam oral solution (concentrate), authorizing a generic version of this…

• FDA approval · 2015-05-18
  FDA Approved: CLONAZEPAM — Supplemental Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare Inc.'s Supplemental Application for clonazepam, making a supplemental approval under the approved ANDA. Clona…

• FDA approval · 2015-04-16
  FDA Approved: DILANTIN — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for DILANTIN (extended phenytoin sodium), a new extended-release form from Viatris Specialty LLC.

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• 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 · 2014-04-14
  FDA Approved: DIAZEPAM — Original Application (Chartwell RX, LLC)

  FDA approved Chartwell RX, LLC's original application for diazepam oral solution (concentrate) as a generic product.

• FDA approval · 2013-09-25
  FDA Approved: FOSPHENYTOIN SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for fosphenytoin sodium by Hikma Pharmaceuticals USA Inc., approving changes to the approved product…

• FDA approval · 2013-09-06
  FDA Approved: DILANTIN-125 — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2013-08-22
  FDA Approved: FOSPHENYTOIN — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Fosphenytoin Sodium (Fosphenytoin) by Fresenius Kabi USA, 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.

• CLINICAL_TRIALS trial_result · 2013-06-03
  Clinical Trial Update: External Trigeminal Nerve Stimulation for Epilepsy [Phase 2]

  A Phase 2 clinical trial evaluating external trigeminal nerve stimulation for epilepsy has completed and results were posted.

• FDA approval · 2013-01-28
  FDA Approved: DIAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for diazepam from Teva Pharmaceuticals USA, Inc., indicating an updated approval-related action for …

• CLINICAL_TRIALS guidance · 2013-01-07
  Clinical Trial Update: Policy on Optimal Epilepsy Management [NA]

  This clinical trial update outlines policy guidance for optimal epilepsy management, highlighting recommended practices for clinicians.

• FDA approval · 2012-11-09
  FDA Approved: LEVETIRACETAM — Supplemental Application (WG Critical Care, LLC)

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

• FDA label_change · 2012-07-19
  FDA Approved: CLONAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for clonazepam to update the labeling of Teva's clonazepam product.

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

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

• FDA approval · 2011-09-15
  FDA Approved: CLONAZEPAM — Supplemental Application (Solco Healthcare LLC)

  FDA approved Solco Healthcare LLC's supplemental application for clonazepam under an approved ANDA.

• FDA approval · 2010-02-26
  FDA Approved: ZONISAMIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for zonisamide submitted by Aurobindo Pharma Limited. The approval confirms the changes requeste…

• FDA approval · 2009-12-23
  FDA Approved: LORAZEPAM — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal Pharmaceuticals' generic lorazepam (oral) under an Original Application (ANDA 091383).

• FDA approval · 2009-12-15
  FDA Approved: PHENYTOIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for phenytoin submitted by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2009-10-15
  FDA Approved: CLONAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for clonazepam filed by Teva Pharmaceuticals USA, Inc., indicating an update under the approved …

• FDA approval · 2009-05-07
  FDA Approved: CLONAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for clonazepam submitted by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2009-01-16
  FDA Approved: LEVETIRACETAM — Original Application (Bionpharma Inc.)

  FDA approved a generic levetiracetam product from Bionpharma Inc. under an Original Application (ANDA 079120), expanding access to this anti…