Epilepsy

• FDA approval · 2025-09-02
  FDA Approved: TOPIRAMATE — Original Application (Ajanta Pharma USA Inc.)

  The FDA approved Ajanta Pharma USA Inc.'s original application for a generic topiramate product. This approval makes generic topiramate avai…

• FDA approval · 2025-08-28
  FDA Approved: BRIVIACT — Supplemental Application (UCB, Inc.)

  FDA approves a supplemental application for Briviact (brivaracetam) from UCB, Inc., resulting in labeling updates for the product.

• FDA approval · 2025-08-28
  FDA Approved: BRIVIACT — Supplemental Application (UCB, Inc.)

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

• EMA approval · 2025-08-27
  EMA Authorised: Pregabalin Accord (pregabalin) — Accord Healthcare S.L.U.

  The EMA authorised the generic pregabalin product Pregabalin Accord for anxiety disorders and epilepsy.

• FDA approval · 2025-08-26
  FDA Approved: GABAPENTIN — Supplemental Application (Granules Pharmaceuticals Inc)

  The FDA approved a supplemental application for Gabapentin from Granules Pharmaceuticals Inc. This approval updates the product's labeling/i…

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• FDA approval · 2025-08-21
  FDA Approved: TOPIRAMATE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approves a supplemental application to add a Topiramate Sprinkle formulation, expanding the available dosage form for topiramate.

• FDA approval · 2025-08-15
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Breckenridge Pharmaceutical, Inc.)

  FDA approved a supplemental application for Oxcarbazepine by Breckenridge Pharmaceutical, Inc.

• FDA approval · 2025-08-15
  FDA Approved: CARBAMAZEPINE ER — Supplemental Application (Bostal LLC)

  FDA approved a supplemental application for Carbamazepine ER submitted by Bostal LLC.

• FDA approval · 2025-08-15
  FDA Approved: LAMOTRIGINE — Supplemental Application (Ajanta Pharma USA Inc.)

  The FDA approved a supplemental application for lamotrigine from Ajanta Pharma USA Inc. under an ANDA.

• FDA approval · 2025-08-12
  FDA Approved: DIVALPROEX SODIUM — Original Application (First Nation Group, LLC)

  FDA approved the original ANDA for divalproex sodium from First Nation Group, LLC, authorizing a generic product to be marketed for the same…

• FDA approval · 2025-08-07
  FDA Approved: GABAPENTIN — Original Application (STALLION LABORATORIES PRIVATE LIMITED)

  The FDA approved Stallion Laboratories Private Limited's Original Application for gabapentin, granting approval of a generic gabapentin prod…

• FDA approval · 2025-08-06
  FDA Approved: LAMOTRIGINE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for Lamotrigine from Unichem Pharmaceuticals (USA), Inc., relating to the generic lamotrigine pr…

• EMA approval · 2025-08-06
  EMA Authorised: Zebinix (eslicarbazepine acetate) — BIAL - Portela & Ca, S.A.

  The European Medicines Agency has authorised Zebinix (eslicarbazepine acetate) by BIAL - Portela & Ca, S.A. for epilepsy. The decision date …

• FDA approval · 2025-07-23
  FDA Approved: TOPIRAMATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Topiramate from Aurobindo Pharma Limited under an existing ANDA.

• FDA approval · 2025-07-23
  FDA Approved: GABAPENTIN — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for gabapentin from Camber Pharmaceuticals, enabling the generic version to be marketed.

• FDA approval · 2025-07-21
  FDA Approved: LACOSAMIDE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for lacosamide filed by Zydus Pharmaceuticals USA Inc., updating the product labeling. This action c…

• FDA approval · 2025-07-11
  FDA Approved: OXCARBAZEPINE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved a generic oxcarbazepine tablet from Macleods Pharmaceuticals Limited under an Original Application (ANDA).

• FDA approval · 2025-07-11
  FDA Approved: PERAMPANEL — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved the original ANDA for PERAMPANEL from Novadoz Pharmaceuticals LLC, making a generic version of perampanel available. This suppo…

• FDA approval · 2025-07-07
  FDA Approved: PREGABALIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved a supplemental application for pregabalin filed by Amneal Pharmaceuticals NY LLC.

• FDA approval · 2025-07-01
  FDA Approved: PREGABALIN CAPSULES, CV — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for Pregabalin Capsules, CV from Cipla USA Inc., under ANDA to market this generic pregabalin capsul…

• FDA approval · 2025-07-01
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Bionpharma Inc.,)

  FDA approved a supplemental application for carbamazepine from Bionpharma Inc. This action confirms regulatory clearance for the product und…

• FDA approval · 2025-06-27
  FDA Approved: LEVETIRACETAM — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application from Prasco Laboratories for a generic version of levetiracetam.

• FDA approval · 2025-06-26
  FDA Approved: LACOSAMIDE ORAL SOLUTION — Original Application (Ajenat Pharmaceuticals LLC)

  The FDA approved lacosamide oral solution under an original generic application (ANDA 219699) from Ajenat Pharmaceuticals LLC.

• FDA approval · 2025-06-24
  FDA Approved: LACOSAMIDE — Supplemental Application (Glenmark Pharmaceuticals Inc. USA)

  FDA approved a supplemental application for lacosamide from Glenmark Pharmaceuticals USA, enabling continued generic lacosamide under the AN…

• FDA approval · 2025-06-17
  FDA Approved: ACETAZOLAMIDE — Original Application (Sagent Pharmaceuticals)

  FDA approved Sagent Pharmaceuticals' Original Application for Acetazolamide, including Acetazolamide and Acetazolamide Sodium formulations.