Migraine

• 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 · 2026-03-31
  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…

• 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 · 2026-03-16
  FDA Approved: NURTEC ODT — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for Nurtec ODT (rimegepant sulfate) from Pfizer, representing an approved supplemental regulatory ac…

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• FDA approval · 2026-03-06
  FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Topamax (topiramate) submitted by Janssen Pharmaceuticals, updating the labeling.

• FDA approval · 2026-03-06
  FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Topamax (topiramate) submitted by Janssen Pharmaceuticals, Inc. This action confirms regulat…

• EMA approval · 2026-02-26
  EMA Authorised: Vydura (rimegepant) — Pfizer Europe MA EEIG

  The European Medicines Agency has authorised Vydura (rimegepant) for migraine disorders, with Pfizer Europe MA EEIG as the marketing authori…

• EMA approval · 2026-02-06
  EMA Authorised: Rayvow (lasmiditan succinate) — Eli Lilly Nederland B.V.

  The EMA authorised Rayvow (lasmiditan succinate) for migraine disorders; the product is manufactured by Eli Lilly Nederland B.V.

• FDA approval · 2026-01-28
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for divalproex sodium submitted by BluePoint Laboratories.

• FDA approval · 2026-01-18
  FDA Approved: TOPIRAMATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approves a supplemental application for TOPIRAMATE from Glenmark Pharmaceuticals Inc., USA.

• FDA approval · 2026-01-12
  FDA Approved: TOPIRAMATE — Original Application (Camber Pharmaceuticals, Inc.)

  This FDA page confirms Camber Pharmaceuticals' original Abbreviated New Drug Application approval for a generic Topiramate product. The appr…

• EMA approval · 2025-12-10
  EMA Authorised: Aimovig (erenumab) — Novartis Europharm Limited

  EMA authorised Aimovig (erenumab) for migraine disorders. Novartis Europharm Limited is listed as the marketing authorisation holder; decisi…

• FDA approval · 2025-12-09
  FDA Approved: IMITREX — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for IMITREX (sumatriptan) submitted by GlaxoSmithKline LLC.

• FDA approval · 2025-12-09
  FDA Approved: SUMATRIPTAN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Sumatriptan submitted by Prasco Laboratories.

• FDA approval · 2025-12-09
  FDA Approved: IMITREX — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Imitrex (sumatriptan) submitted by GlaxoSmithKline LLC. This approval updates the product's …

• FDA approval · 2025-12-04
  FDA Approved: TOPIRAMATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark Pharmaceuticals' supplemental application for Topiramate, enabling a generic version of this anticonvulsant. The a…

• FDA approval · 2025-11-10
  FDA Approved: SUMATRIPTAN AND NAPROXEN SODIUM — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for Sumatriptan and Naproxen Sodium by NorthStar RxLLC. The product is indicated for the acute treat…

• FDA approval · 2025-11-06
  FDA Approved: SUMATRIPTAN SUCCINATE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' Sumatriptan Succinate as an Original Application (ANDA), marking the first generic approval of sumatri…

• FDA approval · 2025-10-23
  FDA Approved: TOPIRAMATE — Supplemental Application (Teva Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Topiramate by Teva Pharmaceuticals under the generic drug pathway.

• FDA approval · 2025-10-22
  FDA Approved: VYEPTI — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for VYEPTI (epinezumab-jjmr) submitted by Lundbeck Pharmaceuticals LLC.

• FDA approval · 2025-10-07
  FDA Approved: TOPIRAMATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental ANDA for Topiramate from Aurobindo Pharma Limited.

• FDA approval · 2025-09-30
  FDA Approved: QULIPTA — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for QULIPTA (atogepant) submitted by AbbVie Inc.

• 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 · 2025-08-21
  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.