Migraine

• FDA approval · 2010-08-12
  FDA Approved: MAXALT — Supplemental Application (Organon LLC)

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

• FDA approval · 2010-08-12
  FDA Approved: MAXALT-MLT — Supplemental Application (Organon LLC)

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

• FDA approval · 2010-08-11
  FDA Approved: IMITREX — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2010-07-28
  FDA Approved: SUMATRIPTAN — Original Application (ONESOURCE SPECIALTY PHARMA LIMITED)

  The FDA approved an original application for a generic Sumatriptan product from Onesource Specialty Pharma Limited. The approval provides a …

• FDA approval · 2010-07-21
  FDA Approved: IMITREX — Supplemental Application (GlaxoSmithKline LLC)

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

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• FDA approval · 2010-07-21
  FDA Approved: RELPAX — Supplemental Application (ROERIG)

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

• FDA approval · 2010-07-21
  FDA Approved: SUMATRIPTAN — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Sumatriptan from Prasco Laboratories.

• FDA approval · 2010-07-07
  FDA Approved: NARATRIPTAN — Original Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved Naratriptan as an original ANDA for Hikma Pharmaceuticals USA Inc., authorizing a generic naratriptan product for the acute…

• FDA approval · 2010-07-06
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (Edenbridge Pharmaceuticals LLC.)

  FDA approved a supplemental application for diclofenac sodium from Edenbridge Pharmaceuticals LLC under the ANDA program. This action consti…

• FDA approval · 2010-06-10
  FDA Approved: SUMATRIPTAN — Original Application (Golden State Medical Supply, Inc.)

  The FDA approved an Original Application (ANDA) for Sumatriptan from Golden State Medical Supply, Inc., approving a generic version of the m…

• FDA approval · 2010-03-15
  FDA Approved: VALPROIC ACID — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved the supplemental application for Valproic Acid filed by PAI Holdings dba PAI Pharma.

• FDA approval · 2010-02-23
  FDA Approved: TOPIRAMATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA supplemental approval for Topiramate by Aurobindo Pharma Limited.

• FDA approval · 2010-02-17
  FDA Approved: VALPROATE SODIUM — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved the original ANDA for valproate sodium, a generic anticonvulsant.

• FDA approval · 2010-02-04
  FDA Approved: EXCEDRIN MIGRAINE GELTABS — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for Excedrin Migraine GelTabs (acetaminophen, aspirin, caffeine) by Haleon US Holdings LLC, likely p…

• FDA approval · 2010-01-27
  FDA Approved: TOPIRAMATE — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for Cipla USA Inc. to market a generic topiramate product.

• FDA approval · 2010-01-20
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for divalproex sodium submitted by Upsher-Smith Laboratories, LLC.

• FDA approval · 2010-01-20
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for divalproex sodium. The approval covers the submitted supplemental chang…

• FDA approval · 2010-01-20
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Bionpharma Inc.)

  FDA approves a supplemental application for divalproex sodium filed by Bionpharma Inc., resulting in an approved update under the ANDA proce…

• FDA approval · 2010-01-12
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

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

• FDA approval · 2010-01-07
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

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

• FDA approval · 2010-01-06
  FDA Approved: VALPROIC ACID — Supplemental Application (Xttrium Laboratories Inc.)

  FDA approved a supplemental application for valproic acid from Xttrium Laboratories Inc., granting approval of a generic product.

• FDA approval · 2009-12-07
  FDA Approved: ERGOMAR SUBLINGUAL — Supplemental Application (Pangea Pharmaceuticals LLC)

  FDA approved a supplemental application for ERGOMAR SUBLINGUAL containing ergotamine tartrate, manufactured by Pangea Pharmaceuticals LLC.

• FDA approval · 2009-11-16
  FDA Approved: BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE — Original Application (Actavis Pharma, Inc.)

  FDA approved the original application for the generic fixed-dose combination of butalbital, acetaminophen, and caffeine (Actavis) for relief…

• FDA approval · 2009-10-14
  FDA Approved: TOPIRAMATE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved an original ANDA for Topiramate Sprinkle from Heritage Pharmaceuticals (d/b/a Avet), a generic version of topiramate. It is ind…

• FDA approval · 2009-10-14
  FDA Approved: TOPIRAMATE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application for Topiramate from Zydus Lifesciences Limited, indicating regulatory approval of a generic Topiramate…