Migraine

• FDA approval · 2022-09-06
  FDA Approved: SUMATRIPTAN SUCCINATE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for Sumatriptan succinate from Dr. Reddy's Laboratories Limited.

• FDA approval · 2022-08-16
  FDA Approved: BUTALBITAL AND ACETAMINOPHEN — Original Application (Aarkish Pharmaceuticals NJ Inc.)

  FDA approved an original application for a generic butalbital and acetaminophen product from Aarkish Pharmaceuticals NJ Inc., authorizing it…

• FDA approval · 2022-08-15
  FDA Approved: AIMOVIG — Supplemental Application (Amgen Inc)

  FDA approved a supplemental application for AIMOVIG (erenumab-aooe) from Amgen Inc, indicating an update to its indication/label.

• FDA approval · 2022-07-15
  FDA Approved: REYVOW — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for REYVOW (lasmiditan) submitted by Eli Lilly and Company.

• FDA approval · 2022-06-22
  FDA Approved: SUMATRIPTAN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Sumatriptan succinate by Aurobindo Pharma Limited, updating an existing Sumatriptan product.

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• FDA approval · 2022-06-17
  FDA Approved: SUMATRIPTAN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Sumatriptan succinate from Aurobindo Pharma Limited, resulting in updated labeling for the produ…

• FDA approval · 2022-05-09
  FDA Approved: DIHYDROERGOTAMINE MESYLATE — Supplemental Application (Oceanside Pharmaceuticals)

  The FDA approved a supplemental application for dihydroergotamine mesylate submitted by Oceanside Pharmaceuticals.

• FDA approval · 2022-04-18
  FDA Approved: ZOLMIPTRIPTAN — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's supplemental application for Zolmitriptan (ZOLMIPTRIPTAN) under ANDA 202560. This represents a supplemental appr…

• FDA approval · 2022-04-11
  FDA Approved: NURTEC ODT — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approves a supplemental application for Nurtec ODT (rimegepant sulfate) from Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2022-04-06
  FDA Approved: FROVATRIPTAN — Original Application (Ingenus Pharmaceuticals, LLC)

  The FDA approved the original application for a generic frovatriptan succinate product (FROVATRIPTAN) from Ingenus Pharmaceuticals for the a…

• FDA approval · 2022-03-04
  FDA Approved: AIMOVIG — Supplemental Application (Amgen Inc)

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

• FDA approval · 2022-02-04
  FDA Approved: TOPIRAMATE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for Topiramate from Upsher-Smith Laboratories, LLC.

• FDA approval · 2022-02-02
  FDA Approved: AMAZON BASIC CARE MIGRAINE RELIEF — Original Application (Amazon.com Services LLC)

  FDA approved an original application for Amazon Basic Care Migraine Relief, a combination of acetaminophen, aspirin, and caffeine, as a gene…

• FDA approval · 2022-01-25
  FDA Approved: REYVOW — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2022-01-13
  FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)

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

• FDA approval · 2021-12-20
  FDA Approved: IMITREX — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2021-12-08
  FDA Approved: NURTEC ODT — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA announces a supplemental application for Nurtec ODT (rimegepant sulfate) from Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2021-12-07
  FDA Approved: EXCEDRIN MIGRAINE GELTABS — Supplemental Application (Haleon US Holdings LLC)

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

• FDA approval · 2021-11-05
  FDA Approved: EPRONTIA — Original Application (Azurity Pharmaceuticals, Inc.)

  FDA approves EPRONTIA (topiramate) from Azurity Pharmaceuticals, Inc. via an original application for approved indications in epilepsy and m…

• FDA approval · 2021-11-03
  FDA Approved: EXCEDRIN MIGRAINE GELTABS — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved a supplemental application to market Excedrin Migraine Geltabs, a new dosage form of the combination product containing ace…

• FDA approval · 2021-10-18
  FDA Approved: BUTALBITAL, ASPIRIN, AND CAFFEINE — Original Application (LGM PHARMA SOLUTIONS, LLC)

  FDA approved the original application for butalbital, aspirin, and caffeine (Butalbital, Aspirin, and Caffeine) submitted by LGM Pharma Solu…

• FDA approval · 2021-09-30
  FDA Approved: ZOLMITRIPTAN — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved the original application for zolmitriptan from Padagis Israel Pharmaceuticals Ltd, marking a new generic entry for acute treatm…

• FDA approval · 2021-09-29
  FDA Approved: AMITRIPTYLINE HYDROCHLORIDE — Supplemental Application (AiPing Pharmaceutical, Inc.)

  FDA approved a supplemental application for Amitriptyline Hydrochloride, a generic product submitted by AiPing Pharmaceutical, Inc., under t…

• FDA approval · 2021-09-28
  FDA Approved: QULIPTA — Original Application (AbbVie Inc.)

  The FDA approved QULIPTA (atogepant) from AbbVie in its original NDA for the preventive treatment of migraine in adults.

• FDA approval · 2021-09-24
  FDA Approved: VYEPTI — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for VYEPTI (eptinezumab-jjmr) submitted by Lundbeck Pharmaceuticals LLC. The action concerns the use…