Migraine

• FDA approval · 2015-09-01
  FDA Approved: SUMATRIPTAN — Supplemental Application (ONESOURCE SPECIALTY PHARMA LIMITED)

  FDA approved a supplemental application for Sumatriptan submitted by Onesource Specialty Pharma Limited.

• FDA approval · 2015-08-24
  FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Naproxen by Hikma Pharmaceuticals USA Inc., indicating changes to the product's approval.

• FDA approval · 2015-08-13
  FDA Approved: SUMATRIPTAN — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Sumatriptan succinate from Aurobindo Pharma Limited under the ANDA.

• FDA approval · 2015-08-13
  FDA Approved: NARATRIPTAN — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Naratriptan from Heritage Pharmaceuticals d/b/a Avet Pharmaceuticals Inc. to market the Nara…

• FDA approval · 2015-07-31
  FDA Approved: BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for the combination drug Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate from Actavis…

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• FDA approval · 2015-06-19
  FDA Approved: SUMATRIPTAN SUCCINATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Sumatriptan succinate from Mylan Pharmaceuticals Inc., indicating approval of a generic migr…

• FDA approval · 2015-06-15
  FDA Approved: MAXALT — Supplemental Application (Organon LLC)

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

• FDA approval · 2015-06-14
  FDA Approved: SUMATRIPTAN SUCCINATE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA approved a supplemental application from Dr. Reddy's Laboratories Limited for Sumatriptan succinate, a generic treatment for acute m…

• FDA approval · 2015-06-12
  FDA Approved: ZOMIG — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for ZOMIG (zolmitriptan) submitted by Amneal Pharmaceuticals LLC.

• FDA approval · 2015-06-11
  FDA Approved: IMITREX — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for IMITREX (sumatriptan) from GlaxoSmithKline LLC.

• FDA approval · 2015-06-02
  FDA Approved: SUMATRIPTAN SUCCINATE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Sumatriptan succinate submitted by Fresenius Kabi USA, LLC.

• FDA approval · 2015-05-29
  FDA Approved: DIVALPROEX SODIUM — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal's generic divalproex sodium product through an Original Application (ANDA 203730).

• FDA approval · 2015-05-14
  FDA Approved: TREXIMET — Supplemental Application (Currax Pharmaceuticals LLC)

  The FDA approved a supplemental application for Treximet, combining sumatriptan succinate and naproxen sodium, submitted by Currax Pharmaceu…

• FDA approval · 2015-05-08
  FDA Approved: TROKENDI XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for TROKENDI XR (topiramate extended-release) submitted by Supernus Pharmaceuticals, Inc. The ac…

• FDA approval · 2015-05-01
  FDA Approved: SUMATRIPTAN SUCCINATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Sumatriptan Succinate from Sun Pharmaceutical Industries, Inc., advancing the generic's regu…

• FDA approval · 2015-04-08
  FDA Approved: RIZATRIPTAN BENZOATE — Supplemental Application (Cipla USA Inc.)

  FDA approved Cipla USA's supplemental application for Rizatriptan Benzoate, enabling its marketing as an approved generic product for the ac…

• FDA approval · 2015-04-07
  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 · 2015-03-13
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental NDA for Depakote Sprinkles (divalproex sodium) from AbbVie, updating labeling and/or indications for the Spr…

• FDA approval · 2015-01-22
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for Propranolol Hydrochloride from Amneal Pharmaceuticals NY LLC, indicating approval for this gener…

• FDA approval · 2015-01-16
  FDA Approved: VALPROIC ACID — Supplemental Application (QUAGEN PHARMACEUTICALS LLC)

  FDA approves a supplemental application for Valproic acid from Quagen Pharmaceuticals LLC (ANDA 090517).

• FDA approval · 2015-01-07
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Depakote ER (divalproex sodium) filed by AbbVie Inc., resulting in a regulatory update to th…

• FDA approval · 2014-12-12
  FDA Approved: DG HEALTH MIGRAINE RELIEF — Supplemental Application (Dolgencorp, LLC)

  FDA approved a supplemental application for Dolgencorp's DG Health Migraine Relief, authorizing the approval of a combination analgesic cont…

• FDA approval · 2014-12-09
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for propranolol hydrochloride by Amneal Pharmaceuticals NY LLC.

• FDA approval · 2014-12-01
  FDA Approved: TOPIRAMATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA granted approval of a supplemental application for Topiramate filed by Unichem Pharmaceuticals (USA), Inc., under an ANDA.

• FDA approval · 2014-12-01
  FDA Approved: TOPIRAMATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for Topiramate from Glenmark Pharmaceuticals, authorizing an update or expansion of its labeling/app…