Migraine

• FDA approval · 2021-09-24
  FDA Approved: AJOVY — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for AJOVY (fremanezumab-vfrm) from Teva Pharmaceuticals USA, Inc. This action updates the product's …

• FDA approval · 2021-09-02
  FDA Approved: TRUDHESA — Original Application (Impel Pharmaceuticals LLC)

  FDA approved TRUDHESA (dihydroergotamine mesylate) from Impel Pharmaceuticals as an original NDA submission for acute treatment of migraine.…

• FDA approval · 2021-08-26
  FDA Approved: TOPIRAMATE — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' generic version of topiramate through an original ANDA.

• FDA approval · 2021-08-13
  FDA Approved: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE — Original Application (Amici Pharma, Inc.)

  The FDA approved Amici Pharma's generic Butalbital, Acetaminophen and Caffeine under an original ANDA, providing a generic option for analge…

• FDA approval · 2021-07-13
  FDA Approved: SUMATRIPTAN — Original Application (Somerset Therapeutics, LLC)

  FDA approves the original application for Sumatriptan from Somerset Therapeutics, LLC, granting a generic version of the acute treatment for…

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• FDA approval · 2021-07-01
  FDA Approved: SUMATRIPTAN SUCCINATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Sumatriptan Succinate from Mylan Pharmaceuticals Inc.

• FDA approval · 2021-06-03
  FDA Approved: REYVOW — Supplemental Application (Eli Lilly and Company)

  The FDA approved Eli Lilly's supplemental application for Reyvow (lasmiditan).

• FDA approval · 2021-05-27
  FDA Approved: NURTEC ODT — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for NURTEC ODT (rimegepant sulfate) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2021-05-19
  FDA Approved: AMITRIPTYLINE HYDROCHLORIDE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved Amitriptyline hydrochloride as an original-application generic from Unichem Pharmaceuticals (USA), Inc. (ANDA 214548).

• FDA approval · 2021-04-28
  FDA Approved: TREXIMET — Supplemental Application (Currax Pharmaceuticals LLC)

  The FDA approved a supplemental application for TREXIMET (sumatriptan succinate and naproxen sodium) from Currax Pharmaceuticals LLC. This a…

• FDA approval · 2021-04-26
  FDA Approved: DICLOFENAC POTASSIUM — Supplemental Application (Trifluent Pharma LLC)

  FDA approved a supplemental application for Diclofenac potassium from Trifluent Pharma LLC as a generic product.

• FDA approval · 2021-04-23
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Aurobindo Pharma Limited)

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

• FDA approval · 2021-04-23
  FDA Approved: NARATRIPTAN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Naratriptan filed by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2021-03-31
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Diclofenac Sodium from Actavis Pharma, Inc. under ANDA074514. The approval covers an updated for…

• FDA approval · 2021-03-23
  FDA Approved: IMITREX — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for IMITREX (sumatriptan) submitted by GlaxoSmithKline LLC. The approval updates the product labelin…

• FDA approval · 2021-03-23
  FDA Approved: IMITREX — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2021-03-04
  FDA Approved: BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for the analgesic combination butalbital/acetaminophen/caffeine/codeine phosphate from Actavis Pharm…

• FDA approval · 2021-03-03
  FDA Approved: UBRELVY — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for UBRELVY (ubrogepant) from Allergan, Inc., resulting in updated labeling for the drug.

• FDA approval · 2021-02-23
  FDA Approved: MIGRAINE RELIEF — Original Application (CHAIN DRUG MARKETING ASSOCIATION, INC.)

  FDA approved Migraine Relief as an original ANDA for a combination analgesic containing acetaminophen, aspirin, and caffeine. The product is…

• FDA approval · 2021-02-22
  FDA Approved: SUMATRIPTAN — Original Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s generic Sumatriptan under an Original Application (ANDA) for the treatment of acute migraine. This marks the a…

• FDA approval · 2021-02-19
  FDA Approved: AMITRIPTYLINE HYDROCHLORIDE — Original Application (Lifestar Pharma LLC)

  FDA-approved Amitriptyline hydrochloride as a generic product via Original Application by Lifestar Pharma LLC.

• FDA approval · 2021-02-17
  FDA Approved: SUMATRIPTAN — Original Application (Florida Pharmaceutical Products, LLC.)

  FDA approved the original application for Sumatriptan from Florida Pharmaceutical Products, LLC, authorizing a generic version of the migrai…

• FDA approval · 2021-02-10
  FDA Approved: DEPAKOTE — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2020-12-04
  FDA Approved: SUMATRIPTAN AND NAPROXEN SODIUM — Supplemental Application (NorthStar RxLLC)

  The FDA approved a supplemental application to market a fixed-dose combination of sumatriptan and naproxen sodium for the acute treatment of…

• FDA approval · 2020-11-24
  FDA Approved: ELETRIPTAN HYDROBROMIDE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Eletriptan hydrobromide from Zydus Pharmaceuticals USA Inc.