Migraine

• FDA approval · 2023-05-04
  FDA Approved: TOPIRAMATE — Original Application (Endo USA, Inc.)

  FDA approves Endo USA, Inc.'s original application for a generic Topiramate. Topiramate is used for epilepsy and migraine prophylaxis.

• FDA approval · 2023-05-03
  FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved Janssen's supplemental application for Topamax (topiramate) and updated the product labeling.

• FDA approval · 2023-04-17
  FDA Approved: EXCEDRIN MIGRAINE GELTABS — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for Excedrin Migraine GelTabs (acetaminophen, aspirin, caffeine) from Haleon US Holdings LLC.

• FDA approval · 2023-04-17
  FDA Approved: QULIPTA — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for QULIPTA (atogepant) from AbbVie Inc., expanding the product's approved indications.

• FDA approval · 2023-04-04
  FDA Approved: PROCHLORPERAZINE MALEATE — Original Application (Bionpharma Inc.)

  FDA approved an Original Application for Prochlorperazine Maleate from Bionpharma Inc., authorizing its marketing as a generic antiemetic.

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• FDA approval · 2023-03-31
  FDA Approved: SUMATRIPTAN SUCCINATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for a generic sumatriptan succinate product from Mylan Pharmaceuticals Inc.

• FDA approval · 2023-03-10
  FDA Approved: TOPIRAMATE — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva's original application for topiramate, making a generic version of the anti-seizure and migraine-prophylaxis medication av…

• FDA approval · 2023-03-09
  FDA Approved: ZAVZPRET — Original Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved the original application for Zavzpret (zavegepant) from Pfizer Inc. for the treatment of migraine.

• FDA approval · 2023-03-08
  FDA Approved: TOPIRAMATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved the supplemental application for Topiramate from Aurobindo Pharma Limited, confirming regulatory clearance for its generic Topi…

• FDA approval · 2023-03-07
  FDA Approved: TOPIRAMATE — Supplemental Application (NorthStar RxLLC)

  The FDA approved a supplemental application for Topiramate submitted by NorthStar RxLLC. The approval indicates changes to the existing prod…

• FDA approval · 2023-03-01
  FDA Approved: TOPIRAMATE — Original Application (Endo USA, Inc.)

  FDA approved Endo USA, Inc.'s original ANDA for a generic Topiramate product.

• FDA approval · 2023-02-24
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2023-02-24
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Depakote ER (divalproex sodium) submitted by AbbVie, expanding the NDA with additional regul…

• FDA approval · 2023-02-17
  FDA Approved: UBRELVY — Supplemental Application (Allergan, Inc.)

  FDA approved Allergan's supplemental application for UBRELVY (ubrogepant), resulting in a label update for its use in treating acute migrain…

• FDA approval · 2023-02-08
  FDA Approved: DIHYDROERGOTAMINE MESYLATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for dihydroergotamine mesylate (ANDA 040453).

• FDA approval · 2023-01-25
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approves a supplemental application for divalproex sodium submitted by Ajanta Pharma USA Inc.

• FDA approval · 2023-01-19
  FDA Approved: SUMATRIPTAN — Original Application (Baxter Healthcare Corporation)

  This FDA entry documents the original approval of sumatriptan by Baxter Healthcare Corporation for the acute treatment of migraine.

• FDA approval · 2022-12-27
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Aurobindo Pharma Limited)

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

• FDA approval · 2022-11-28
  FDA Approved: TOPIRAMATE — Original Application (Zydus Lifesciences Limited)

  FDA approved Zydus Lifesciences Limited's Original Application for a generic Topiramate. Topiramate is used for epilepsy and migraine prophy…

• FDA approval · 2022-11-21
  FDA Approved: TOPIRAMATE — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for Topiramate (generic Topiramate) from NorthStar RxLLC under an ANDA.

• FDA approval · 2022-11-16
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for divalproex sodium, authorizing changes to the approved generic product unde…

• FDA approval · 2022-10-21
  FDA Approved: VYEPTI — Supplemental Application (Lundbeck Pharmaceuticals LLC)

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

• FDA approval · 2022-10-20
  FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Topamax (topiramate) submitted by Janssen Pharmaceuticals.

• FDA approval · 2022-09-22
  FDA Approved: AIMOVIG — Supplemental Application (Amgen Inc)

  The FDA approved a supplemental application for AIMOVIG (erenumab-aooe) submitted by Amgen Inc. The action updates the labeling to reflect t…

• FDA approval · 2022-09-15
  FDA Approved: REYVOW — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for Reyvow (lasmiditan) from Eli Lilly and Company.