Migraine

• FDA approval · 2016-11-16
  FDA Approved: ONZETRA XSAIL — Supplemental Application (Currax Pharmaceuticals LLC)

  FDA approved a supplemental application for ONZETRA XSAIL (sumatriptan succinate) by Currax Pharmaceuticals LLC.

• FDA approval · 2016-11-02
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA approved a Supplemental Application for Depakote Sprinkles (divalproex sodium) submitted by AbbVie Inc.

• FDA approval · 2016-11-02
  FDA Approved: DEPAKOTE — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote (divalproex sodium) from AbbVie Inc. The action updates labeling or indications related…

• FDA approval · 2016-09-06
  FDA Approved: SUMATRIPTAN SUCCINATE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for Sumatriptan Succinate by Dr. Reddy's Laboratories Limited, granting approval of their generic pr…

• FDA approval · 2016-06-23
  FDA Approved: SUMATRIPTAN — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Sumatriptan from Bionpharma Inc., updating the approval status of this generic migraine medicati…

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• FDA approval · 2016-05-20
  FDA Approved: ZOLMITRIPTAN — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA's generic zolmitriptan for the acute treatment of migraine with or without aura (ANDA 204041).

• FDA approval · 2016-05-19
  FDA Approved: RIZATRIPTAN BENZOATE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for Rizatriptan Benzoate from Ascend Laboratories, LLC, for a generic rizatriptan benzoate product.

• FDA approval · 2016-05-12
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2016-05-11
  FDA Approved: ZOLMITRIPTAN — Original Application (Rising Pharma Holdings, Inc.)

  FDA approves Rising Pharma Holdings, Inc.'s original Abbreviated New Drug Application for zolmitriptan tablets (generic zolmitriptan). This …

• FDA approval · 2016-05-09
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (Aurobindo Pharma Limited)

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

• FDA approval · 2016-05-09
  FDA Approved: TREXIMET — Supplemental Application (Currax Pharmaceuticals LLC)

  The FDA approved a supplemental application for Treximet, the combination of sumatriptan succinate and naproxen sodium, submitted by Currax …

• FDA approval · 2016-04-29
  FDA Approved: EXCEDRIN MIGRAINE GELTABS — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for Excedrin Migraine Geltabs, a combination of acetaminophen, aspirin, and caffeine, from Haleon US…

• FDA approval · 2016-03-25
  FDA Approved: FIORICET WITH CODEINE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for Fioricet with Codeine from Actavis Pharma, Inc., authorizing continued marketing of this com…

• FDA approval · 2016-03-25
  FDA Approved: SUMATRIPTAN — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Sumatriptan submitted by Prasco Laboratories, indicating an approved modification or additio…

• FDA approval · 2016-03-11
  FDA Approved: FROVATRIPTAN SUCCINATE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's frovatriptan succinate as an Original Application (ANDA) for the acute treatment of migraine.

• FDA approval · 2016-03-03
  FDA Approved: ALMOTRIPTAN — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s original application for Almotriptan, a generic treatment for acute migraine.

• FDA approval · 2016-02-26
  FDA Approved: DG HEALTH MIGRAINE RELIEF — Supplemental Application (Dolgencorp, LLC)

  FDA approved a supplemental application for Dolgencorp's DG Health Migraine Relief, a combination product of acetaminophen, aspirin, and caf…

• FDA approval · 2016-02-19
  FDA Approved: SUMATRIPTAN — Original Application (Lannett Company, Inc.)

  The FDA approved Lannett Company's generic sumatriptan product under an original ANDA for the acute treatment of migraine.

• FDA approval · 2016-02-18
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote ER (divalproex sodium) from AbbVie Inc., granting an additional regulatory authorizatio…

• FDA approval · 2016-02-18
  FDA Approved: RIZATRIPTAN BENZOATE — Original Application (Ascend Laboratories, LLC)

  FDA approved a generic Rizatriptan Benzoate product (ANDA 203269) from Ascend Laboratories for the acute treatment of migraine. This represe…

• FDA approval · 2016-02-09
  FDA Approved: SUMATRIPTAN SUCCINATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Sumatriptan succinate by Sun Pharmaceutical Industries, Inc. The submission concerns a generic p…

• FDA approval · 2016-02-03
  FDA Approved: ZOLMITRIPTAN — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Zolmitriptan (Zydus Pharmaceuticals USA Inc.), confirming regulatory action related to the produ…

• FDA approval · 2016-01-28
  FDA Approved: EXCEDRIN MIGRAINE GELTABS — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for Excedrin Migraine GelTabs, authorizing the gel-tab formulation containing acetaminophen, aspirin…

• FDA approval · 2016-01-28
  FDA Approved: ZEMBRACE SYMTOUCH — Original Application (Upsher-Smith laboratories, LLC)

  FDA approved Zembrace SymTouch (sumatriptan succinate) from Upsher-Smith Laboratories as an original application for the acute treatment of …

• FDA approval · 2016-01-27
  FDA Approved: ONZETRA XSAIL — Original Application (Currax Pharmaceuticals LLC)

  The FDA approved the original application for ONZETRA XSAIL (sumatriptan succinate) from Currax Pharmaceuticals LLC. It is intended for the …