Migraine

• FDA approval · 2024-11-21
  FDA Approved: BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE — Supplemental Application (Amneal Pharmaceuticals of New York, LLC)

  FDA granted supplemental approval for Amneal's generic product containing butalbital, aspirin, caffeine, and codeine phosphate.

• FDA approval · 2024-11-05
  FDA Approved: TOPIRAMATE — Original Application (Vitruvias Therapeutics, Inc.)

  FDA approves Vitruvias Therapeutics' generic Topiramate through an Original Application (ANDA), expanding access as a generic option for epi…

• FDA approval · 2024-10-31
  FDA Approved: BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Actavis's fixed-dose combination analgesic Butalbital, Acetaminophen, Caffeine, and Codeine Phos…

• FDA approval · 2024-10-31
  FDA Approved: FIORICET WITH CODEINE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved Actavis Pharma, Inc.'s supplemental application for Fioricet with Codeine (butalbital, acetaminophen, caffeine, and codeine…

• FDA approval · 2024-10-31
  FDA Approved: TOPIRAMATE — Original Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' original ANDA for topiramate, providing a generic version of this anticonvulsant and migraine preventi…

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• FDA approval · 2024-10-23
  FDA Approved: TOPIRAMATE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Topiramate from Zydus Lifesciences Limited under an ANDA.

• EMA approval · 2024-10-16
  EMA Authorised: Vyepti (Eptinezumab) — H. Lundbeck A/S

  The European Medicines Agency has authorised Vyepti (eptinezumab) by H. Lundbeck A/S for migraine disorders.

• FDA approval · 2024-09-10
  FDA Approved: TOPIRAMATE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Topiramate from Zydus Lifesciences Limited, granting approval for a generic version of the anti-…

• FDA approval · 2024-08-28
  FDA Approved: DIHYDROERGOTAMINE MESYLATE — Supplemental Application (Provepharm Inc.)

  FDA approved a supplemental application for dihydroergotamine mesylate from Provepharm Inc. under ANDA212046.

• FDA approval · 2024-08-06
  FDA Approved: AIMOVIG — Supplemental Application (Amgen Inc)

  The FDA approved a supplemental application for AIMOVIG (erenumab-aooe) submitted by Amgen.

• FDA approval · 2024-07-16
  FDA Approved: TOPIRAMATE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approves Glenmark's Original Application for Topiramate, a generic anticonvulsant. Topiramate is approved for certain seizure disorders …

• FDA approval · 2024-07-11
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for propranolol hydrochloride by Lannett Company, Inc., approving changes to the existing ANDA to su…

• FDA approval · 2024-06-14
  FDA Approved: CAFERGOT — Supplemental Application (Trifluent Pharma, LLC)

  FDA approved a supplemental application for CAFERGOT, a migraine treatment containing ergotamine tartrate and caffeine, submitted by Triflue…

• FDA approval · 2024-06-13
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for divalproex sodium from Aurobindo Pharma Limited.

• FDA approval · 2024-06-13
  FDA Approved: TOPIRAMATE — Original Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' original application for a generic topiramate product.

• FDA approval · 2024-06-05
  FDA Approved: SUMATRIPTAN — Supplemental Application (Cipla USA Inc.)

  The FDA approved a supplemental application for Sumatriptan from Cipla USA Inc., supporting marketing of this generic migraine medication. T…

• FDA approval · 2024-05-23
  FDA Approved: SUMATRIPTAN — Supplemental Application (Eugia US LLC)

  FDA approval of a supplemental application for Sumatriptan from Eugia US LLC under an ANDA, indicating an updated regulatory submission for …

• FDA approval · 2024-05-17
  FDA Approved: FROVATRIPTAN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for Frovatriptan succinate from Amneal Pharmaceuticals NY LLC. This action updates the product label…

• FDA approval · 2024-05-17
  FDA Approved: EPRONTIA — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for EPRONTIA (topiramate) submitted by Azurity Pharmaceuticals, Inc.

• FDA approval · 2024-03-18
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Depakote ER (divalproex sodium) submitted by AbbVie Inc.

• FDA approval · 2024-03-18
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA approved AbbVie's supplemental application for Depakote Sprinkles (divalproex sodium).

• FDA approval · 2024-02-15
  FDA Approved: DIHYDROERGOTAMINE MESYLATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for dihydroergotamine mesylate by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2024-02-13
  FDA Approved: ELETRIPTAN HYDROBROMIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Eletriptan Hydrobromide from Teva Pharmaceuticals USA, Inc. This action updates the approved…

• FDA approval · 2024-02-01
  FDA Approved: BUTALBITAL AND ACETAMINOPHEN — Original Application (QUAGEN PHARMACEUTICALS LLC)

  FDA approves an original ANDA for Butalbital and Acetaminophen from Quagen Pharmaceuticals LLC.

• FDA approval · 2024-01-18
  FDA Approved: TOPIRAMATE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Topiramate from Zydus Lifesciences Limited. The action updates the product labeling and may expa…