Partial Seizures

• FDA approval · 2021-03-05
  FDA Approved: GABAPENTIN — Supplemental Application (Granules Pharmaceuticals Inc)

  FDA approved Granules Pharmaceuticals Inc's supplemental application for gabapentin granules, approving a new granulated formulation of a ge…

• FDA approval · 2020-10-20
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved a supplemental application for Sabril (vigabatrin) submitted by Lundbeck Pharmaceuticals LLC. The action updates the approv…

• FDA approval · 2020-08-25
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved a supplemental application for oxcarbazepine from Glenmark Pharmaceuticals Inc., USA. This action represents a regulatory u…

• FDA approval · 2020-08-07
  FDA Approved: GABAPENTIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for gabapentin from Sun Pharmaceutical Industries, Inc., granting supplemental approval for this…

• FDA approval · 2020-04-17
  FDA Approved: VIGABATRIN — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for Vigabatrin submitted by Par Health USA, LLC. This action updates the regulatory status for V…

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• FDA approval · 2019-05-31
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for Sabril (vigabatrin) from Lundbeck Pharmaceuticals LLC. The action completes an approved suppleme…

• FDA approval · 2019-05-31
  FDA Approved: FELBAMATE — Original Application (Novitium Pharma LLC)

  FDA approved an Original Application for felbamate by Novitium Pharma LLC, enabling a generic felbamate product for seizure disorders. The p…

• FDA approval · 2018-05-14
  FDA Approved: GABAPENTIN — Original Application (ACI Healthcare USA, Inc.)

  FDA approved an Original Application (ANDA) for Gabapentin by ACI Healthcare USA, Inc., authorizing a generic gabapentin product.

• FDA approval · 2018-03-13
  FDA Approved: VIGABATRIN — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal's generic version of vigabatrin under an Original Application (ANDA 210155), enabling marketing of the drug for its esta…

• FDA approval · 2018-03-08
  FDA Approved: FOSPHENYTOIN SODIUM — Supplemental Application (West-Ward Pharmaceuticals Corp)

  FDA approved a supplemental application for fosphenytoin sodium submitted by West-Ward Pharmaceuticals Corp. The action updates labeling for…

• FDA approval · 2017-04-27
  FDA Approved: VIGABATRIN — Original Application (Par Health USA, LLC)

  FDA approves Vigabatrin original Abbreviated New Drug Application for Par Health USA, LLC (generic entry).

• FDA approval · 2017-04-20
  FDA Approved: FELBAMATE — Original Application (Taro Pharmaceuticals U.S.A., inc.)

  FDA approves the original ANDA application for Felbamate from Taro Pharmaceuticals U.S.A., enabling a generic version of the antiepileptic d…

• FDA approval · 2016-02-26
  FDA Approved: ZONISAMIDE — Supplemental Application (Exelan Pharmaceuticals, Inc.)

  FDA approved a supplemental application for zonisamide (Exelan Pharmaceuticals) under ANDA077869. This action relates to the approved generi…

• FDA approval · 2016-02-18
  FDA Approved: GABAPENTIN — Original Application (ScieGen Pharmaceuticals, Inc.)

  FDA approved the original generic application for gabapentin from ScieGen Pharmaceuticals, Inc., establishing a generic version of gabapenti…

• FDA approval · 2015-12-23
  FDA Approved: OXTELLAR XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for OXTELLAR XR (oxcarbazepine) by Supernus Pharmaceuticals, Inc.

• FDA approval · 2015-11-12
  FDA Approved: ZONEGRAN — Supplemental Application (Advanz Pharma (US) Corp.)

  FDA approved a supplemental application for Zonegran (zonisamide) submitted by Advanz Pharma (US) Corp.

• FDA approval · 2015-09-11
  FDA Approved: OXTELLAR XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)

  FDA approved a supplemental application for OXTELLAR XR (oxcarbazepine) from Supernus Pharmaceuticals, Inc.

• FDA approval · 2015-04-24
  FDA Approved: ZONISAMIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves a supplemental application for Zonisamide by Sun Pharmaceutical Industries, Inc., indicating a regulatory modification for the …

• FDA approval · 2015-01-20
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Breckenridge Pharmaceutical, Inc.)

  The FDA approved Breckenridge Pharmaceutical, Inc.'s supplemental application for oxcarbazepine under the ANDA.

• FDA approval · 2014-03-25
  FDA Approved: GABAPENTIN — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for gabapentin from BluePoint Laboratories, granting approval of a generic version under ANDA077…

• FDA approval · 2012-12-11
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved Lundbeck's supplemental application for SABRIL (vigabatrin), updating the labeling per NDA020427. This approval reflects ch…

• FDA approval · 2012-04-26
  FDA Approved: LEVETIRACETAM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for Levetiracetam by Dr. Reddy's Laboratories Limited under the ANDA, reflecting an approved additio…

• FDA approval · 2011-11-04
  FDA Approved: TIAGABINE HYDROCHLORIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical Industries, Inc. tiagabine hydrochloride tablets as an original generic approval for adjunctive treatmen…

• FDA approval · 2011-09-13
  FDA Approved: FELBAMATE — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved the original ANDA for felbamate from Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2011-08-30
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Breckenridge Pharmaceutical, Inc.)

  The FDA approved a supplemental application for oxcarbazepine from Breckenridge Pharmaceutical, Inc.