Migraine

• FDA approval · 2014-11-20
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2014-11-20
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Dr. Reddy's Laboratories Ltd)

  FDA approved a supplemental application for divalproex sodium from Dr. Reddy's Laboratories Ltd.

• FDA approval · 2014-11-20
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2014-11-18
  FDA Approved: TOPIRAMATE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for Topiramate submitted by Zydus Lifesciences Limited.

• FDA approval · 2014-11-02
  FDA Approved: NAPROXEN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for Naproxen by Amneal Pharmaceuticals of New York LLC (generic Naproxen).

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• FDA approval · 2014-10-29
  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 · 2014-09-19
  FDA Approved: RIZATRIPTAN BENZOATE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved Rizatriptan benzoate as an original application generic from Macleods Pharmaceuticals Limited for the treatment of acute migrai…

• FDA approval · 2014-09-19
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (BluePoint Laboratories)

  FDA approves a supplemental application for Divalproex Sodium by BluePoint Laboratories, indicating clearance of a supplemental filing for a…

• FDA approval · 2014-08-05
  FDA Approved: VALPROIC ACID — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for Valproic acid submitted by Upsher-Smith Laboratories, LLC.

• FDA approval · 2014-07-30
  FDA Approved: EXCEDRIN MIGRAINE GELTABS — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved Haleon's supplemental NDA for Excedrin Migraine Geltabs, adding a new dosage form of the combination therapy (acetaminophen…

• FDA approval · 2014-07-15
  FDA Approved: EXCEDRIN MIGRAINE GELTABS — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental NDA for Excedrin Migraine GelTabs, confirming a combination product containing acetaminophen, aspirin, and caffe…

• FDA approval · 2014-06-19
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  The FDA granted a supplemental approval for Depakote Sprinkles (divalproex sodium) from AbbVie under a supplemental application.

• FDA approval · 2014-06-19
  FDA Approved: DEPAKOTE — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote (divalproex sodium) submitted by AbbVie Inc. The approval indicates the agency has appr…

• FDA approval · 2014-06-09
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote Sprinkles (divalproex sodium) submitted by AbbVie. The action involves Depakote Sprinkl…

• FDA approval · 2014-06-09
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2014-06-02
  FDA Approved: DIVALPROEX SODIUM — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's original ANDA for divalproex sodium, enabling a generic version of the drug.

• FDA approval · 2014-05-29
  FDA Approved: MAXALT-MLT — Supplemental Application (Organon LLC)

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

• FDA approval · 2014-05-13
  FDA Approved: TREXIMET — Supplemental Application (Currax Pharmaceuticals LLC)

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

• FDA approval · 2014-04-18
  FDA Approved: TROKENDI XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for TROKENDI XR (topiramate extended-release) from Supernus Pharmaceuticals, Inc. The action may…

• FDA approval · 2014-04-15
  FDA Approved: EXCEDRIN MIGRAINE GELTABS — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for Excedrin Migraine GelTabs, a combination product of acetaminophen, aspirin, and caffeine, by Hal…

• FDA approval · 2014-04-09
  FDA Approved: ZOLMITRIPTAN — Original Application (Cipla USA Inc.)

  FDA approves Cipla USA Inc.'s original ANDA for zolmitriptan, authorizing the marketing of a generic zolmitriptan product for migraine treat…

• FDA approval · 2014-03-20
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for divalproex sodium submitted by Sun Pharmaceutical Industries.

• FDA approval · 2014-03-18
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for DIVALPROEX SODIUM submitted by Bionpharma Inc.

• FDA approval · 2014-03-14
  FDA Approved: SUMATRIPTAN SUCCINATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Sumatriptan succinate from Sun Pharmaceutical Industries, Inc.

• FDA approval · 2014-03-11
  FDA Approved: TOPIRAMATE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved the original application for Topiramate from Upsher-Smith Laboratories, LLC.