Epilepsy

• FDA approval · 2022-10-12
  FDA Approved: VIGABATRIN FOR ORAL SOLUTION — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' supplemental application for Vigabatrin as an oral solution, adding a new formulation of the antiep…

• FDA approval · 2022-10-12
  FDA Approved: VIGABATRIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Vigabatrin by Aurobindo Pharma Limited under ANDA213899.

• FDA approval · 2022-10-12
  FDA Approved: VIGABATRIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA granted supplemental approval for Vigabatrin from Amneal Pharmaceuticals NY LLC under ANDA210042, enabling a revised/expanded approval f…

• FDA approval · 2022-10-12
  FDA Approved: VIGABATRIN — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for Vigabatrin submitted by Ascend Laboratories, LLC.

• FDA approval · 2022-10-12
  FDA Approved: VIGABATRIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Vigabatrin submitted by Aurobindo Pharma Limited, indicating regulatory action to authorize this…

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• FDA approval · 2022-10-12
  FDA Approved: VIGABATRIN — Supplemental Application (Hikma Pharmaceuticals USA Inc)

  FDA approved a supplemental application for Vigabatrin submitted by Hikma Pharmaceuticals USA Inc, representing an additional regulatory act…

• FDA approval · 2022-10-12
  FDA Approved: VIGABATRIN — Supplemental Application (Edenbridge Pharmaceuticals LLC.)

  FDA approved a supplemental application for Vigabatrin from Edenbridge Pharmaceuticals LLC. under ANDA 215109.

• FDA approval · 2022-10-06
  FDA Approved: CARBAMAZEPINE — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' generic carbamazepine under Original Application ANDA214277.

• FDA approval · 2022-10-03
  FDA Approved: BRIVARACETAM — Original Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a generic version of brivaracetam (BRIVARACETAM) from Zydus Pharmaceuticals USA Inc. under Original Application ANDA214501.

• FDA approval · 2022-09-30
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Vimpat (lacosamide) filed by UCB, Inc., signaling an FDA-approved expansion or modification to t…

• FDA approval · 2022-09-30
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for VIMPAT (lacosamide) submitted by UCB, Inc., resulting in a labeling update for the drug.

• FDA approval · 2022-09-19
  FDA Approved: LACOSAMIDE — Original Application (Gland Pharma Limited)

  FDA approved an original application for lacosamide from Gland Pharma Limited to market a generic lacosamide product. The approval covers it…

• FDA approval · 2022-09-14
  FDA Approved: LACOSAMIDE — Original Application (XLCare Pharmaceuticals Inc.)

  The FDA approves XLCare Pharmaceuticals' original ANDA for lacosamide, making a generic lacosamide available in the market.

• FDA approval · 2022-09-07
  FDA Approved: DILANTIN — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Dilantin to authorize an extended phenytoin sodium formulation. This product is manufactured…

• FDA approval · 2022-09-07
  FDA Approved: VIGABATRIN — Original Application (Novadoz Pharmaceuticals LLC)

  The FDA approved the original Abbreviated New Drug Application for vigabatrin from Novadoz Pharmaceuticals LLC, yielding a generic version o…

• FDA approval · 2022-08-30
  FDA Approved: OXCARBAZEPINE — Original Application (Advagen Pharma Ltd)

  FDA approves the original application for oxcarbazepine from Advagen Pharma Ltd, granting approval for a generic version of the antiseizure …

• FDA approval · 2022-08-29
  FDA Approved: VIGABATRIN — Original Application (Hikma Pharmaceuticals USA Inc)

  FDA approved Hikma's generic Vigabatrin under an Original Application (ANDA 213104). This notice confirms approval of a generic Vigabatrin p…

• FDA approval · 2022-08-26
  FDA Approved: LACOSAMIDE — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' Original Abbreviated New Drug Application for lacosamide, authorizing the marketing of a generic lacosamid…

• FDA approval · 2022-08-25
  FDA Approved: ETHOSUXIMIDE — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for Ethosuximide submitted by Strides Pharma Science Limited.

• FDA approval · 2022-08-24
  FDA Approved: FOSPHENYTOIN SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for fosphenytoin sodium submitted by Amneal Pharmaceuticals LLC.

• FDA approval · 2022-08-22
  FDA Approved: CARBAMAZEPINE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved the Original Application for generic carbamazepine from Unichem Pharmaceuticals (USA), Inc.

• FDA approval · 2022-08-18
  FDA Approved: CARBAMAZEPINE — Original Application (Northstar Rx LLC)

  FDA approved the original generic application for Carbamazepine from Northstar Rx LLC, authorizing a generic version of the anticonvulsant. …

• FDA approval · 2022-08-16
  FDA Approved: ETHOSUXIMIDE — Supplemental Application (Epic Pharma, LLC)

  FDA approved a supplemental application for Ethosuximide filed by Epic Pharma, LLC.

• FDA approval · 2022-08-08
  FDA Approved: VIGADRONE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for Vigadrone (vigabatrin) from Upsher-Smith Laboratories, LLC.

• FDA approval · 2022-07-27
  FDA Approved: LAMOTRIGINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application for the lamotrigine generic product from Alembic Pharmaceuticals Limited, reflecting a regulator…