Migraine

• FDA approval · 2020-11-24
  FDA Approved: ELETRIPTAN HYDROBROMIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Eletriptan hydrobromide from Aurobindo Pharma Limited, authorizing its continued use as a ge…

• FDA approval · 2020-11-18
  FDA Approved: TROKENDI XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Trokendi XR (topiramate) from Supernus Pharmaceuticals, indicating an update to its labeling.

• FDA approval · 2020-10-30
  FDA Approved: VALPROIC ACID — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Valproic Acid submitted by ANI Pharmaceuticals, Inc.

• FDA approval · 2020-10-26
  FDA Approved: NARATRIPTAN — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for Naratriptan by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., permitting the sal…

• FDA approval · 2020-10-06
  FDA Approved: RIZATRIPTAN BENZOATE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for Rizatriptan Benzoate from Rising Pharma Holdings, Inc., authorizing the generic Rizatriptan …

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• FDA approval · 2020-09-30
  FDA Approved: ELETRIPTAN HYDROBROMIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Eletriptan hydrobromide from Mylan Pharmaceuticals Inc., authorizing a generic version for t…

• FDA approval · 2020-09-29
  FDA Approved: ALMOTRIPTAN MALATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves a supplemental application for Almotriptan Malate (Teva Pharmaceuticals USA, Inc.), granting regulatory approval for this gener…

• FDA approval · 2020-09-21
  FDA Approved: RIZATRIPTAN BENZOATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for Rizatriptan Benzoate from Glenmark Pharmaceuticals Inc., USA.

• FDA approval · 2020-09-21
  FDA Approved: SUMATRIPTAN — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approves Padagis Israel Pharmaceuticals Ltd's SUMATRIPTAN as an original ANDA generic for the acute treatment of migraines.

• FDA approval · 2020-08-25
  FDA Approved: SUMATRIPTAN — Supplemental Application (Eugia US LLC)

  The FDA approved a supplemental application for Sumatriptan submitted by Eugia US LLC. This pertains to an existing Sumatriptan product.

• FDA approval · 2020-08-18
  FDA Approved: NURTEC ODT — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Nurtec ODT (rimegepant sulfate) from Pfizer Laboratories Div Pfizer Inc, updating the drug's…

• FDA approval · 2020-07-20
  FDA Approved: SUMATRIPTAN — Supplemental Application (SUN PHARMACEUTICAL INDUSTRIES, INC.)

  The FDA approved a supplemental application for Sumatriptan from Sun Pharmaceutical Industries, resulting in changes to the product's labeli…

• FDA approval · 2020-07-20
  FDA Approved: SUMATRIPTAN — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for Sumatriptan from Bionpharma Inc. under the ANDA program, updating the regulatory status of t…

• FDA approval · 2020-07-20
  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 · 2020-07-20
  FDA Approved: SUMATRIPTAN — Supplemental Application (Golden State Medical Supply, Inc.)

  FDA approved a supplemental application for Sumatriptan submitted by Golden State Medical Supply, Inc., under the ANDA.

• FDA approval · 2020-07-20
  FDA Approved: SUMATRIPTAN — Supplemental Application (ONESOURCE SPECIALTY PHARMA LIMITED)

  FDA approved a supplemental application for SUMATRIPTAN from ONESOURCE SPECIALTY PHARMA LIMITED, approving a modification to the existing ge…

• FDA approval · 2020-07-17
  FDA Approved: REYVOW — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for Reyvow (lasmiditan) from Eli Lilly and Company.

• FDA approval · 2020-07-01
  FDA Approved: SUMATRIPTAN SUCCINATE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for Sumatriptan succinate (Dr. Reddy's Laboratories Limited).

• FDA approval · 2020-06-24
  FDA Approved: SUMATRIPTAN AND NAPROXEN SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for the generic Sumatriptan and Naproxen Sodium from Aurobindo Pharma Limited.

• FDA approval · 2020-06-09
  FDA Approved: ZOLMITRIPTAN — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Zolmitriptan filed by Zydus Pharmaceuticals USA Inc., indicating regulatory approval for a m…

• FDA approval · 2020-05-20
  FDA Approved: DIHYDROERGOTAMINE MESYLATE NASAL — Original Application (Cipla USA Inc.)

  The FDA approved Cipla's dihydroergotamine mesylate nasal spray as an original generic application, making a generic version of the acute mi…

• FDA approval · 2020-05-19
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Depakote Sprinkles (divalproex sodium) from AbbVie, updating labeling/indications for the pr…

• FDA approval · 2020-05-08
  FDA Approved: IBUPROFEN — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's ibuprofen generic under Original Application (ANDA213794). The product is a generic version of ibupr…

• FDA approval · 2020-04-21
  FDA Approved: VALPROIC ACID — Supplemental Application (Chartwell Governmental & Specialty RX, LLC.)

  FDA approved a supplemental application for valproic acid (generic) submitted by Chartwell Governmental & Specialty RX, LLC.

• FDA approval · 2020-04-13
  FDA Approved: SUMATRIPTAN SUCCINATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Sumatriptan Succinate from Sun Pharmaceutical Industries, Inc., indicating regulatory approval r…