Epilepsy

• FDA approval · 2011-03-03
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tegretol (carbamazepine) from Novartis Pharmaceuticals Corporation, authorizing changes to the p…

• FDA approval · 2011-03-03
  FDA Approved: TRILEPTAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for TRILEPTAL (oxcarbazepine) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2011-03-01
  FDA Approved: NEURONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for Neurontin (gabapentin) from the Parke-Davis Division of Pfizer Inc, resulting in an updated …

• FDA approval · 2011-02-25
  FDA Approved: FLUDEOXYGLUCOSE F 18 — Original Application (PETNET Solutions, Inc.)

  The FDA approved an original application for Fludeoxyglucose F-18 (FDG F-18) as a radiopharmaceutical for PET imaging, submitted by PETNET S…

• FDA approval · 2011-02-18
  FDA Approved: GABAPENTIN — Original Application (BioComp Pharma, Inc.)

  FDA approved BioComp Pharma, Inc.'s original application for gabapentin, granting generic status and permission to market the product. Gabap…

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• FDA approval · 2011-02-11
  FDA Approved: GABAPENTIN — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approves Zydus Pharmaceuticals USA Inc.'s Gabapentin under an original ANDA, authorizing a generic gabapentin product.

• FDA approval · 2011-01-27
  FDA Approved: PHENYTOIN SODIUM — Supplemental Application (Acella Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Phenytoin Sodium submitted by Acella Pharmaceuticals, LLC.

• FDA approval · 2011-01-25
  FDA Approved: VALPROIC ACID — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Valproic acid submitted by Bionpharma Inc.

• FDA approval · 2011-01-21
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for divalproex sodium submitted by NorthStar Rx LLC.

• FDA approval · 2011-01-18
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for Sabril (vigabatrin) submitted by Lundbeck Pharmaceuticals LLC.

• FDA approval · 2011-01-18
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for Sabril (vigabatrin) submitted by Lundbeck Pharmaceuticals LLC.

• FDA approval · 2011-01-17
  FDA Approved: DILANTIN-125 — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for DILANTIN-125 (phenytoin) from Viatris Specialty LLC, reflecting an approved addition/modificatio…

• FDA approval · 2011-01-13
  FDA Approved: LAMOTRIGINE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approves Alembic Pharmaceuticals Limited's generic lamotrigine under an Original Application for marketing in the United States. This ap…

• FDA approval · 2011-01-12
  FDA Approved: LAMOTRIGINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for Lamotrigine from Dr. Reddy's Laboratories Limited, advancing the approval status of its generic …

• FDA approval · 2011-01-10
  FDA Approved: GABAPENTIN — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for gabapentin from Aurobindo Pharma Limited, marking a supplemental approval for this generic g…

• FDA approval · 2010-12-28
  FDA Approved: TOPIRAMATE — Supplemental Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s supplemental application for Topiramate under ANDA 079162 for the generic product.

• FDA approval · 2010-12-28
  FDA Approved: TOPIRAMATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved the supplemental application for Topiramate submitted by Unichem Pharmaceuticals (USA), Inc., under ANDA090162.

• FDA approval · 2010-12-23
  FDA Approved: TOPIRAMATE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for TOPIRAMATE SPINKLE, a sprinkle formulation of topiramate manufactured by Heritage Pharmaceutical…

• FDA approval · 2010-12-17
  FDA Approved: GABAPENTIN — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories, LLC's Original Application for gabapentin (generic), authorizing its use for partial seizures in epilepsy …

• FDA approval · 2010-12-15
  FDA Approved: LEVETIRACETAM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for levetiracetam from Sun Pharmaceutical Industries, Inc., updating the approval status for this ge…

• FDA approval · 2010-12-13
  FDA Approved: LEVETIRACETAM — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for levetiracetam submitted by BluePoint Laboratories, enabling the generic product’s approval.

• FDA approval · 2010-12-13
  FDA Approved: LEVETIRACETAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for levetiracetam from Aurobindo Pharma Limited, authorizing a generic Levetiracetam product under a…

• FDA approval · 2010-11-30
  FDA Approved: PRIMIDONE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for PRIMIDONE from Dr. Reddy's Laboratories Limited.

• FDA approval · 2010-11-30
  FDA Approved: PRIMIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's supplemental application for Primidone under the approved ANDA.

• FDA approval · 2010-11-17
  FDA Approved: LEVETIRACETAM — Supplemental Application (Actavis Pharma, Inc.)

  FDA approves a supplemental application for levetiracetam by Actavis Pharma, Inc., approving an updated generic product.