Epilepsy

• FDA approval · 2025-05-30
  FDA Approved: ACETAZOLAMIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's original application for a generic acetazolamide product.

• EMA approval · 2025-05-28
  EMA Authorised: Lacosamide Accord (lacosamide) — Accord Healthcare S.L.U.

  The European Medicines Agency authorised Lacosamide Accord for epilepsy. The product contains lacosamide and is marketed by Accord Healthcar…

• FDA approval · 2025-05-27
  FDA Approved: TOPIRAMATE — Original Application (Advagen Pharma Ltd)

  FDA approved the original ANDA for Topiramate by Advagen Pharma Ltd, providing a generic version of the anticonvulsant. The drug is indicate…

• FDA approval · 2025-05-23
  FDA Approved: LACOSAMIDE — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals' lacosamide generic under Original Application (ANDA218706), expanding access to lacosamide for the…

• FDA approval · 2025-05-23
  FDA Approved: PERAMPANEL — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva Pharmaceuticals' original application for a generic version of perampanel. The product is manufactured by Teva Pharmaceuti…

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• FDA approval · 2025-04-30
  FDA Approved: PREGABALIN — Supplemental Application (Cipla USA, Inc.)

  The FDA approved Cipla's supplemental application to market a generic pregabalin product, enabling a generic version of the drug for its app…

• FDA approval · 2025-04-25
  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, updating the product labeling…

• FDA approval · 2025-04-25
  FDA Approved: LAMICTAL XR — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Lamictal XR (lamotrigine) submitted by GlaxoSmithKline LLC. This action authorizes changes r…

• FDA approval · 2025-04-25
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2025-04-15
  FDA Approved: VALTOCO — Supplemental Application (Neurelis, Inc)

  FDA approved a supplemental application for VALTOCO (diazepam nasal spray) from Neurelis, Inc., resulting in changes to the product labeling…

• EMA approval · 2025-04-15
  EMA Authorised: Inovelon (rufinamide) — Eisai GmbH

  EMA authorised Inovelon (rufinamide) by Eisai GmbH for epilepsy, following a decision on 28 November 2023.

• FDA approval · 2025-04-15
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for divalproex sodium.

• FDA approval · 2025-04-04
  FDA Approved: LEVETIRACETAM — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Levetiracetam (generic) submitted by Fresenius Kabi USA, LLC, under ANDA090876.

• FDA approval · 2025-03-27
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for divalproex sodium (divalproex) by Aurobindo Pharma Limited. The approval pertains to the generic…

• FDA approval · 2025-03-26
  FDA Approved: LEVETIRACETAM — Supplemental Application (Dr.Reddy's Laboratories Inc)

  FDA approved a supplemental application for LEVETIRACETAM INJECTION by Dr. Reddy's Laboratories, adding an injectable formulation of levetir…

• FDA approval · 2025-03-21
  FDA Approved: PRIMIDONE — Supplemental Application (Carnegie Pharmaceuticals LLC)

  FDA approved a supplemental application for Primidone (PRIMIDONE) from Carnegie Pharmaceuticals LLC, approving the supplemental submission f…

• FDA approval · 2025-03-17
  FDA Approved: LEVETIRACETAM — Supplemental Application (Civica, Inc.)

  FDA approved a supplemental application for LEVETIRACETAM by Civica, Inc. under ANDA 090981.

• FDA approval · 2025-03-17
  FDA Approved: LEVETIRACETAM — Supplemental Application (Mylan Institutional LLC)

  FDA granted a supplemental approval for LEVETIRACETAM (levetiracetam) by Mylan Institutional LLC under ANDA 203308. This action approves cha…

• FDA approval · 2025-03-13
  FDA Approved: GABAPENTIN — Supplemental Application (Granules Pharmaceuticals Inc.)

  FDA approved Granules Pharmaceuticals' supplemental application for gabapentin to add a granule formulation.

• FDA approval · 2025-03-12
  FDA Approved: TOPIRAMATE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for Topiramate from Upsher-Smith Laboratories, LLC. The document indicates an approval action relate…

• FDA approval · 2025-03-12
  FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for TOPAMAX (topiramate) filed by Janssen Pharmaceuticals, Inc.

• FDA approval · 2025-03-10
  FDA Approved: TROKENDI XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for TROKENDI XR (topiramate) submitted by Supernus Pharmaceuticals, Inc. The approval updates th…

• FDA approval · 2025-03-10
  FDA Approved: LEVETIRACETAM — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental application for Levetiracetam in Sodium Chloride from Eugia US LLC, adding a salt-form formulation of levetirace…

• FDA approval · 2025-03-05
  FDA Approved: LEVETIRACETAM IN SODIUM CHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for levetiracetam in sodium chloride, a new injectable formulation by Hikma Pharmaceuticals USA Inc.…

• FDA approval · 2025-03-04
  FDA Approved: LEVETIRACETAM — Supplemental Application (Actavis Pharma, Inc.)

  FDA approves a supplemental application for levetiracetam submitted by Actavis Pharma, Inc.