Migraine

• FDA approval · 2014-02-19
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for divalproex sodium from Unichem Pharmaceuticals (USA), Inc., indicating an approved change or add…

• FDA approval · 2014-02-11
  FDA Approved: RIZATRIPTAN — Original Application (Macleods Pharmaceuticals Limited)

  FDA approves the original application for Rizatriptan from Macleods Pharmaceuticals Limited.

• FDA approval · 2014-02-11
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for divalproex sodium from Zydus Pharmaceuticals USA Inc.

• FDA approval · 2014-02-05
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (NorthStar Rx LLC)

  The FDA approved a supplemental application for divalproex sodium submitted by NorthStar Rx LLC.

• FDA approval · 2014-01-29
  FDA Approved: SUMATRIPTAN SUCCINATE — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories Limited's sumatriptan succinate as an original ANDA, providing a generic version of sumatriptan for th…

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• FDA approval · 2013-12-03
  FDA Approved: RELPAX — Supplemental Application (ROERIG)

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

• FDA approval · 2013-11-25
  FDA Approved: SUMATRIPTAN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Sumatriptan submitted by Prasco Laboratories. This action yields a supplemental approval for the…

• FDA approval · 2013-11-25
  FDA Approved: IMITREX — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for IMITREX (sumatriptan) from GlaxoSmithKline LLC. This action represents an approval of a suppleme…

• FDA approval · 2013-11-19
  FDA Approved: INNOPRAN XL — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' supplemental application for INNOPRAN XL (propranolol hydrochloride). The approval confirms changes to the…

• FDA approval · 2013-11-07
  FDA Approved: RELPAX — Supplemental Application (ROERIG)

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

• FDA approval · 2013-10-03
  FDA Approved: RELPAX — Supplemental Application (ROERIG)

  The FDA approved a supplemental application for Relpax (eletriptan hydrobromide) submitted by Roerig.

• FDA approval · 2013-09-16
  FDA Approved: ZOMIG — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for ZOMIG (zolmitriptan) from Amneal Pharmaceuticals LLC, resulting in changes to the product labeli…

• FDA approval · 2013-09-16
  FDA Approved: SUMATRIPTAN — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s Sumatriptan generic under an Original Application (ANDA200183).

• FDA approval · 2013-09-05
  FDA Approved: NARATRIPTAN — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for Naratriptan submitted by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. under an …

• FDA approval · 2013-08-16
  FDA Approved: TROKENDI XR — Original Application (Supernus Pharmaceuticals, Inc.)

  FDA approved TROKENDI XR (topiramate extended-release) in an Original Application by Supernus Pharmaceuticals, expanding the topiramate port…

• FDA approval · 2013-07-31
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote ER (divalproex sodium) from AbbVie Inc. This action represents an approved supplement t…

• FDA approval · 2013-07-01
  FDA Approved: RIZATRIPTAN BENZOATE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark’s Rizatriptan Benzoate as a generic formulation for the acute treatment of migraine, representing the original gen…

• FDA approval · 2013-07-01
  FDA Approved: RIZATRIPTAN BENZOATE — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved Rising Pharma's original ANDA for Rizatriptan Benzoate, a generic version of rizatriptan benzoate for the acute treatment o…

• FDA approval · 2013-07-01
  FDA Approved: RIZATRIPTAN BENZOATE — Original Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s Rizatriptan Benzoate as an original generic (ANDA) approval for the treatment of acute migraine.

• FDA approval · 2013-06-14
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2013-05-15
  FDA Approved: ZOLMITRIPTAN — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved the original ANDA for zolmitriptan from Zydus Pharmaceuticals USA Inc., making a generic version available for the acute treatm…

• FDA approval · 2013-05-14
  FDA Approved: ZOLMIPTRIPTAN — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approves Glenmark's ZOLMIPTRIPTAN (zolmitriptan) as a generic under an original ANDA, enabling market entry for acute treatment of migra…

• FDA approval · 2013-05-14
  FDA Approved: ZOLMITRIPTAN — Original Application (Glenmark Pharmaceuticals Inc.,USA)

  FDA approved Glenmark's original ANDA for zolmitriptan tablets, providing a generic option for the treatment of acute migraine.

• FDA approval · 2013-04-23
  FDA Approved: SUMATRIPTAN — Original Application (Eugia US LLC)

  FDA approved the original ANDA for Sumatriptan from Eugia US LLC, making a generic Sumatriptan product available.

• FDA approval · 2013-02-27
  FDA Approved: DEPAKOTE — Supplemental Application (AbbVie Inc.)

  The FDA approved AbbVie's supplemental application for DEPAKOTE (divalproex sodium), updating regulatory labeling as part of the supplementa…