Partial-onset Seizures

• EMA approval · 2026-04-08
  EMA Authorised: Fycompa (perampanel) — Eisai GmbH

  The European Medicines Agency authorised Fycompa (perampanel) by Eisai GmbH for partial-onset seizures in epilepsy.

• FDA approval · 2026-02-24
  FDA Approved: PREGABALIN — Original Application (FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED)

  FDA approved the original Abbreviated New Drug Application for pregabalin from Fourrts (India) Laboratories Private Limited, granting a gene…

• FDA approval · 2026-02-23
  FDA Approved: BRIVARACETAM ORAL SOLUTION — Original Application (Ascend Laboratories, LLC)

  The FDA approved an original application for a generic brivaracetam oral solution from Ascend Laboratories, enabling a generic formulation f…

• FDA approval · 2026-02-23
  FDA Approved: BRIVARACETAM — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s original application for a generic version of brivaracetam. The generic is approved for the treatment of partial…

• FDA approval · 2026-02-23
  FDA Approved: BRIVARACETAM — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved the original abbreviated new drug application for a generic Brivaracetam product from Novadoz Pharmaceuticals LLC. Brivaracetam…

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• FDA approval · 2026-02-23
  FDA Approved: BRIVARACETAM — Original Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' generic version of brivaracetam through an original ANDA, expanding access to an antiseizure medicat…

• FDA approval · 2026-01-30
  FDA Approved: BRIVARACETAM — Supplemental Application (SolarisPharmaCorporation)

  The FDA approved a supplemental application for brivaracetam from SolarisPharmaCorporation, signaling regulatory action to update the drug's…

• FDA approval · 2026-01-29
  FDA Approved: LACOSAMIDE ORAL SOLUTION — Original Application (Florida Pharmaceutical Products, LLC)

  FDA approved the original application for Lacosamide Oral Solution from Florida Pharmaceutical Products, LLC, adding a generic formulation f…

• FDA approval · 2026-01-21
  FDA Approved: LACOSAMIDE — Original Application (GLENMARK PHARMACEUTICALS INC., USA)

  FDA approved Glenmark Pharmaceuticals' lacosamide original application, authorizing a generic lacosamide product. Lacosamide is used for the…

• FDA approval · 2025-11-25
  FDA Approved: PERAMPANEL — Original Application (Novadoz Pharmaceuticals LLC)

  The FDA approved the original application for a generic form of perampanel from Novadoz Pharmaceuticals LLC.

• FDA approval · 2025-10-15
  FDA Approved: LACOSAMIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for lacosamide, a generic anticonvulsant, under the ANDA framework. The notice…

• FDA approval · 2025-09-17
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for Oxcarbazepine filed by Glenmark Pharmaceuticals Inc., USA.

• FDA approval · 2025-09-17
  FDA Approved: PREGABALIN — Supplemental Application (MARKSANS PHARMA LIMITED)

  The FDA approved a supplemental application for pregabalin from Marksans Pharma Limited, resulting in approval of a generic pregabalin produ…

• 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.

• FDA approval · 2025-08-21
  FDA Approved: PREGABALIN — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental ANDA for pregabalin, authorizing the marketing of a generic pregabalin product.

• FDA approval · 2025-08-21
  FDA Approved: PREGABALIN — Supplemental Application (ScieGen Pharmaceuticals, Inc)

  FDA approved a supplemental application for pregabalin from ScieGen Pharmaceuticals, Inc., confirming approval of the generic product under …

• FDA approval · 2025-08-18
  FDA Approved: PREGABALIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Pregabalin submitted by Rising Pharma Holdings, Inc. under the approved ANDA.

• FDA approval · 2025-08-15
  FDA Approved: PREGABALIN — Supplemental Application (Indoco Remedies Limited)

  FDA approved a supplemental application for pregabalin from Indoco Remedies Limited, resulting in approval of a generic pregabalin product.

• FDA approval · 2025-07-21
  FDA Approved: PREGABALIN — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' supplemental application for pregabalin. The approval enables the marketing of a generic pregabalin pr…

• FDA approval · 2025-07-21
  FDA Approved: PREGABLIN — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for pregabalin from Macleods Pharmaceuticals Limited, authorizing a generic version of the drug. Thi…

• 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: 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 (Torrent Pharmaceuticals Limited)

  FDA approves a supplemental application for Pregabalin from Torrent Pharmaceuticals Limited, enabling the generic drug to be marketed.

• 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.