Migraine

• FDA approval · 2020-04-09
  FDA Approved: TOPIRAMATE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Topiramate from Zydus Lifesciences Limited under ANDA207382, granting additional approval relate…

• FDA approval · 2020-04-08
  FDA Approved: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE — Original Application (Granules Pharmaceuticals Inc.)

  FDA approved the original application for a generic fixed-dose combination of butalbital, acetaminophen, and caffeine (Granules Pharmaceutic…

• FDA approval · 2020-03-24
  FDA Approved: RELPAX — Supplemental Application (ROERIG)

  FDA approves a supplemental application for RELPAX (eletriptan hydrobromide) submitted by ROERIG.

• FDA approval · 2020-03-16
  FDA Approved: NARATRIPTAN — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for Naratriptan submitted by Bionpharma Inc., signaling an updated approval for Naratriptan prod…

• FDA approval · 2020-02-28
  FDA Approved: DIHYDROERGOTAMINE MESYLATE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved an original-application generic formulation of dihydroergotamine mesylate from Hikma Pharmaceuticals USA Inc.

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• FDA approval · 2020-02-27
  FDA Approved: NURTEC ODT — Original Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approves Nurtec ODT (rimegepant sulfate) under its original NDA for the acute treatment of migraine in adults.

• FDA approval · 2020-02-27
  FDA Approved: EXCEDRIN MIGRAINE GELTABS — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for Excedrin Migraine Geltabs (acetaminophen, aspirin, caffeine) submitted by Haleon US Holdings LLC…

• FDA approval · 2020-02-21
  FDA Approved: VYEPTI — Original Application (Lundbeck Pharmaceuticals LLC)

  FDA approved VYEPTI (eptinezumab-jjmr) under an original Biologics License Application for the preventive treatment of chronic migraine in a…

• FDA approval · 2020-02-21
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Dr. Reddy's Laboratories Ltd)

  The FDA approved a supplemental application for divalproex sodium from Dr. Reddy's Laboratories Ltd, indicating an update to its labeling. T…

• FDA approval · 2020-02-20
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Dr. Reddy's Laboratories Ltd)

  The FDA approved a supplemental application for divalproex sodium submitted by Dr. Reddy's Laboratories Ltd. This action denotes an approved…

• FDA approval · 2020-02-15
  FDA Approved: AIMOVIG — Supplemental Application (Amgen Inc)

  FDA approved a supplemental application for AIMOVIG (erenumab-aooe) from Amgen.

• FDA approval · 2020-02-14
  FDA Approved: TOPIRAMATE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for topiramate submitted by Upsher-Smith Laboratories, LLC, resulting in an update to the produc…

• FDA approval · 2020-02-09
  FDA Approved: RIZATRIPTAN BENZOATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for rizatriptan benzoate from Unichem Pharmaceuticals (USA), Inc., enabling the generic product to b…

• FDA approval · 2020-02-02
  FDA Approved: RIZATRIPTAN BENZOATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for rizatriptan benzoate, enabling a generic version of the acute migraine medication to reach …

• FDA approval · 2020-01-30
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' supplemental application for divalproex sodium, resulting in an approved change to the product u…

• FDA approval · 2020-01-29
  FDA Approved: RIZATRIPTAN BENZOATE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved Rising Pharma Holdings, Inc.'s supplemental application for Rizatriptan Benzoate, enabling the marketing of a generic rizat…

• FDA approval · 2020-01-29
  FDA Approved: RIZATRIPTAN BENZOATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's supplemental application for rizatriptan benzoate, a migraine medication, under an ANDA, authorizing changes to …

• FDA approval · 2020-01-27
  FDA Approved: ZOLMITRIPTAN — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for zolmitriptan from Alembic Pharmaceuticals Inc. under an ANDA.

• FDA approval · 2020-01-27
  FDA Approved: AJOVY — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for AJOVY (fremanezumab) submitted by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2020-01-22
  FDA Approved: RIZATRIPTAN BENZOATE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for Rizatriptan Benzoate (Ascend Laboratories, LLC) under the existing ANDA, indicating an update to…

• FDA approval · 2020-01-14
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for divalproex sodium submitted by Lupin Pharmaceuticals, Inc.

• FDA approval · 2020-01-13
  FDA Approved: ZOLMITRIPTAN — Supplemental Application (Glenmark Pharmaceuticals Inc.,USA)

  The FDA approved Glenmark's supplemental application for zolmitriptan, a generic product. This action confirms the continued market availabi…

• FDA approval · 2020-01-09
  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.

• FDA approval · 2020-01-08
  FDA Approved: ZOLMITRIPTAN — Supplemental Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s supplemental application for zolmitriptan under the ANDA framework.

• FDA approval · 2020-01-07
  FDA Approved: DIHYDROERGOTAMINE MESYLATE — Original Application (Provepharm Inc.)

  FDA approved an original ANDA for dihydroergotamine mesylate from Provepharm Inc., providing a generic option for treating migraines. This r…