Migraine

• FDA approval · 2013-02-19
  FDA Approved: TOPIRAMATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for Topiramate from Unichem Pharmaceuticals (USA), Inc., confirming approval of a supplemental chang…

• FDA approval · 2012-12-31
  FDA Approved: RIZATRIPTAN BENZOATE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's rizatriptan benzoate as an original generic application for the acute treatment of migraine.

• FDA approval · 2012-12-31
  FDA Approved: RIZATRIPTAN BENZOATE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Rizatriptan benzoate Original Application (ANDA) from Teva as a generic rizatriptan benzoate product for acute treatment of mig…

• FDA approval · 2012-12-31
  FDA Approved: RIZATRIPTAN BENZOATE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approves the original application for Rizatriptan benzoate (Rizatriptan benzoate) by Rising Pharma Holdings, Inc. (ANDA 202490).

• FDA approval · 2012-12-31
  FDA Approved: RIZATRIPTAN BENZOATE — Original Application (Creekwood Pharmaceuticals LLC)

  FDA approved Creekwood Pharmaceuticals LLC's Rizatriptan Benzoate Original Application, establishing a generic version of rizatriptan for th…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2012-11-08
  FDA Approved: MIGERGOT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for MIGERGOT (ergotamine tartrate and caffeine) from Cosette Pharmaceuticals, Inc.

• FDA approval · 2012-10-29
  FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Topamax (topiramate) submitted by Janssen Pharmaceuticals, Inc. The approval pertains to changes…

• FDA approval · 2012-10-29
  FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)

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

• FDA approval · 2012-10-02
  FDA Approved: IMITREX — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2012-08-10
  FDA Approved: SUMATRIPTAN — Supplemental Application (SUN PHARMACEUTICAL INDUSTRIES, INC.)

  The FDA approved a supplemental application for Sumatriptan submitted by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2012-08-10
  FDA Approved: SUMATRIPTAN — Supplemental Application (SUN PHARMACEUTICAL INDUSTRIES, INC.)

  FDA approved a supplemental application for Sumatriptan from Sun Pharmaceutical Industries, Inc. The approval updates the regulatory status …

• FDA approval · 2012-06-18
  FDA Approved: MIGERGOT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Migergot (ergotamine tartrate and caffeine) from Cosette Pharmaceuticals, Inc. This action a…

• FDA approval · 2012-04-27
  FDA Approved: SUMATRIPTAN — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for Sumatriptan from Bionpharma Inc., supporting a generic product entry under an approved ANDA.

• FDA approval · 2012-04-20
  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 · 2012-03-15
  FDA Approved: DIVALPROEX SODIUM — Original Application (Dr. Reddy's Laboratories Ltd)

  The FDA approved Dr. Reddy's Laboratories' original application for divalproex sodium, a generic anticonvulsant, for use in conditions such …

• FDA approval · 2012-03-01
  FDA Approved: IMITREX — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2012-03-01
  FDA Approved: TREXIMET — Supplemental Application (Currax Pharmaceuticals LLC)

  The FDA approved a supplemental application for TREXIMET (sumatriptan succinate and naproxen sodium) filed by Currax Pharmaceuticals LLC.

• FDA approval · 2012-03-01
  FDA Approved: SUMATRIPTAN — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Sumatriptan submitted by Prasco Laboratories.

• FDA approval · 2012-01-27
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Ipca Laboratories Limited)

  FDA approved a supplemental application for propranolol hydrochloride from Ipca Laboratories Limited, finalizing a regulatory update for the…

• FDA approval · 2012-01-11
  FDA Approved: SUMATRIPTAN SUCCINATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Sumatriptan Succinate from Mylan Pharmaceuticals Inc., resulting in regulatory approval for …

• FDA approval · 2011-12-16
  FDA Approved: MAXALT — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for MAXALT (rizatriptan benzoate) submitted by Organon LLC.

• FDA approval · 2011-12-16
  FDA Approved: MAXALT-MLT — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for MAXALT-MLT (rizatriptan benzoate) by Organon LLC.

• FDA approval · 2011-11-14
  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.

• FDA approval · 2011-10-11
  FDA Approved: NARATRIPTAN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Naratriptan from Hikma Pharmaceuticals USA Inc. under ANDA090381, enabling the marketing of a ge…

• FDA approval · 2011-09-23
  FDA Approved: TREXIMET — Supplemental Application (Currax Pharmaceuticals LLC)

  The FDA approved a supplemental application for TREXIMET, submitted by Currax Pharmaceuticals LLC.