Epilepsy

• EMA approval · 2026-08-20
  EMA Authorised: Vimpat (lacosamide) — UCB Pharma SA

  Authorised status for Vimpat (lacosamide) by EMA under UCB Pharma SA for epilepsy.

• EMA approval · 2026-08-11
  EMA Authorised: Zebinix (eslicarbazepine acetate) — BIAL - Portela & Ca, S.A.

  Zebinix (eslicarbazepine acetate) has been authorised in the European Union for epilepsy by BIAL.

• FDA approval · 2026-08-10
  FDA Approved: BRIVARACETAM — Original Application (Aurobindo Pharma Limited)

  FDA approval overview for the generic anticonvulsant brivaracetam marketed by Aurobindo Pharma Limited.

• EMA approval · 2026-08-07
  EMA Authorised: Lacosamide Adroiq (lacosamide) — Extrovis EU Ltd

  EMA has authorised Lacosamide Adroiq (lacosamide) for epilepsy with Extrovis EU Ltd as manufacturer.

• EMA approval · 2026-07-01
  EMA Authorised: Ontozry (cenobamate) — Angelini Pharma S.p.A

  EMA has authorised Ontozry (cenobamate) for epilepsy, with Angelini Pharma S.p.A as the marketing authorization holder.

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• FDA approval · 2026-04-21
  FDA Approved: LEVETIRACETAM — Supplemental Application (Patrin Pharma, Inc.)

  The FDA approved a supplemental application for levetiracetam from Patrin Pharma, Inc., marking an approved change to the product's labeling…

• FDA approval · 2026-04-13
  FDA Approved: LAMOTRIGINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for Lamotrigine from Alembic Pharmaceuticals Limited under ANDA 090607.

• FDA approval · 2026-04-10
  FDA Approved: LAMOTRIGINE KIT — Supplemental Application (OWP Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Lamotrigine Kit, a generic lamotrigine product by OWP Pharmaceuticals, Inc.

• FDA approval · 2026-04-09
  FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Lamotrigine submitted by Aurobindo Pharma Limited.

• FDA approval · 2026-04-09
  FDA Approved: LAMOTRIGINE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for a generic lamotrigine product from Unichem Pharmaceuticals (USA), Inc.

• FDA approval · 2026-04-08
  FDA Approved: LEVETIRACETAM SOLUTION — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for LEVETIRACETAM SOLUTION from Chartwell RX, LLC, granting approval under the ANDA process.

• 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 · 2026-04-08
  FDA Approved: VALPROIC ACID — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Valproic Acid from Bionpharma Inc., for a generic product under ANDA 073484. This action confirm…

• FDA approval · 2026-04-01
  FDA Approved: LAMOTRIGINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Lamotrigine from Sun Pharmaceutical Industries, Inc.

• EMA approval · 2026-04-01
  EMA Authorised: Keppra (levetiracetam) — UCB Pharma SA

  Keppra (levetiracetam) has been authorised in the EU for epilepsy. The marketing authorization holder is UCB Pharma SA.

• FDA approval · 2026-03-31
  FDA Approved: VALPROIC ACID — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for valproic acid submitted by ANI Pharmaceuticals, Inc. The approval covers changes to the product …

• FDA approval · 2026-03-31
  FDA Approved: VALPROIC ACID — Supplemental Application (Xttrium Laboratories Inc.)

  FDA approved a supplemental application for VALPROIC ACID from Xttrium Laboratories Inc. The approval concerns changes to the generic produc…

• EMA approval · 2026-03-25
  EMA Authorised: Lyrica (pregabalin) — Upjohn EESV

  The European Medicines Agency authorised pregabalin (brand Lyrica) for epilepsy, anxiety disorders, and neuralgia, with Upjohn EESV as the m…

• FDA approval · 2026-03-20
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's supplemental application for carbamazepine, reflecting an update to the product's labeling un…

• FDA approval · 2026-03-20
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for carbamazepine from Alembic Pharmaceuticals, enabling changes to the product's labeling.

• FDA approval · 2026-03-18
  FDA Approved: TOPIRAMATE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for Topiramate by Ascend Laboratories, LLC.

• FDA approval · 2026-03-18
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved a supplemental application for Sabril (vigabatrin) submitted by Lundbeck Pharmaceuticals LLC.

• FDA approval · 2026-03-18
  FDA Approved: VIGABATRIN — Supplemental Application (Novadoz Pharmaceuticals LLC)

  The FDA approved a supplemental application for Vigabatrin submitted by Novadoz Pharmaceuticals LLC.

• FDA approval · 2026-03-18
  FDA Approved: VIGABATRIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for Vigabatrin by Amneal Pharmaceuticals NY LLC.

• FDA approval · 2026-03-18
  FDA Approved: VIGABATRIN — Supplemental Application (Cipla USA, Inc.)

  The FDA approved Cipla USA, Inc.'s supplemental application for Vigabatrin, resulting in an approved change to the labeling for the product.…