Migraine

• FDA approval · 2025-03-21
  FDA Approved: QULIPTA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2025-03-21
  FDA Approved: UBRELVY — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for Ubrelvy (ubrogepant) from Allergan, Inc.

• FDA approval · 2025-03-17
  FDA Approved: SUMATRIPTAN — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for Rising Pharma Holdings' Sumatriptan generic product under an ANDA. This marks an update to t…

• FDA approval · 2025-03-12
  FDA Approved: TOPIRAMATE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for Topiramate from Upsher-Smith Laboratories, LLC. The document indicates an approval action relate…

• FDA approval · 2025-03-12
  FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for TOPAMAX (topiramate) filed by Janssen Pharmaceuticals, Inc.

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• FDA approval · 2025-03-10
  FDA Approved: TROKENDI XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for TROKENDI XR (topiramate) submitted by Supernus Pharmaceuticals, Inc. The approval updates th…

• FDA approval · 2025-03-07
  FDA Approved: ALMOTRIPTAN — Supplemental Application (Ajanta Pharma USA Inc.)

  The FDA approved a supplemental application for ALMOTRIPTAN (almotriptan) from Ajanta Pharma USA Inc., signaling an update to the product's …

• FDA approval · 2025-02-26
  FDA Approved: TOPIRAMATE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for Topiramate by Ascend Laboratories, LLC (ANDA 217795), resulting in an updated regulatory action …

• FDA approval · 2025-02-26
  FDA Approved: DIHYDROERGOTAMINE MESYLATE — Original Application (Somerset Therapeutics, LLC)

  FDA approved Somerset Therapeutics, LLC's generic dihydroergotamine mesylate under an original ANDA for the acute treatment of migraine.

• FDA approval · 2025-02-11
  FDA Approved: ZOLMITRIPTAN OD — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved a supplemental application to authorize Zolmitriptan Oral Disintegrating Tablet (OD) for acute treatment of migraine, manufactu…

• FDA approval · 2025-01-30
  FDA Approved: SYMBRAVO — Original Application (Axsome Therapeutics, Inc.)

  FDA approved SYMBRAVO, a fixed-dose combination of meloxicam and rizatriptan from Axsome Therapeutics, under an original NDA for the acute t…

• FDA approval · 2025-01-23
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2025-01-22
  FDA Approved: PROCHLORPERAZINE EDISYLATE — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental application for Prochlorperazine edisylate from Eugia US LLC. The approval pertains to a supplemental submission…

• FDA approval · 2025-01-21
  FDA Approved: BUTALBITAL, ASPIRIN, AND CAFFEINE — Supplemental Application (LGM PHARMA SOLUTIONS, LLC)

  The FDA approved a supplemental application for the generic fixed-dose combination of butalbital, aspirin, and caffeine. The product is manu…

• FDA approval · 2025-01-07
  FDA Approved: DIHYDROERGOTAMINE MESYLATE — Original Application (Baxter Healthcare Corporation)

  The FDA approved Baxter Healthcare Corporation's dihydroergotamine mesylate as an original ANDA generic product. The approval covers the gen…

• FDA approval · 2024-12-31
  FDA Approved: SUMATRIPTAN — Original Application (Rising Pharma Holdings, Inc.)

  FDA approval of a generic Sumatriptan product (Original Application) by Rising Pharma Holdings, Inc. for acute treatment of migraine.

• FDA approval · 2024-12-12
  FDA Approved: SUMATRIPTAN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Sumatriptan from Hikma Pharmaceuticals USA Inc., updating the regulatory status of this prod…

• FDA approval · 2024-12-12
  FDA Approved: NURTEC ODT — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for NURTEC ODT (rimegepant sulfate) from Pfizer Laboratories Div Pfizer Inc, related to the prod…

• FDA approval · 2024-12-05
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for divalproex sodium submitted by Unichem Pharmaceuticals (USA), Inc. under ANDA079163. This ac…

• FDA approval · 2024-11-26
  FDA Approved: TOPIRAMATE — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for Topiramate submitted by NorthStar RxLLC.

• FDA approval · 2024-11-21
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for a generic diclofenac sodium product from NorthStar Rx LLC.

• FDA approval · 2024-11-21
  FDA Approved: TREXIMET — Supplemental Application (Currax Pharmaceuticals LLC)

  FDA approved a supplemental application for TREXIMET, the combination of sumatriptan succinate and naproxen sodium, by Currax Pharmaceutical…

• FDA approval · 2024-11-21
  FDA Approved: BUTALBITAL, ASPIRIN, AND CAFFEINE — Supplemental Application (Westminster Pharmaceuticals, LLC)

  FDA approved a supplemental application for a generic combination product containing butalbital, aspirin, and caffeine from Westminster Phar…

• FDA approval · 2024-11-21
  FDA Approved: SUMATRIPTAN — Original Application (ONESOURCE SPECIALTY PHARMA LIMITED)

  The FDA approved an original application for Sumatriptan from Onesource Specialty Pharma Limited, granting a generic form of sumatriptan. Th…

• FDA approval · 2024-11-21
  FDA Approved: BUTALBITAL, ASPIRIN, AND CAFFEINE — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental ANDA from Lannett Company to market a generic Butalbital, Aspirin, and Caffeine product.