Epilepsy

• FDA approval · 2023-10-06
  FDA Approved: ESLICARBAZEPINE ACETATE — Original Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories, LLC's eslicarbazepine acetate as an original generic application. It is indicated as adjunctive therap…

• FDA approval · 2023-10-02
  FDA Approved: LEVETIRACETAM — Original Application (Baxter Healthcare Corporation)

  FDA approved Baxter Healthcare Corporation's original-application generic levetiracetam (ANDA 217059) for seizure disorders, establishing a …

• FDA approval · 2023-09-27
  FDA Approved: TOPIRAMATE — Original Application (Aurobindo Pharma Limited)

  FDA approves the Original Application for Topiramate (generic) by Aurobindo Pharma Limited. Topiramate is used as an anticonvulsant for epil…

• FDA approval · 2023-09-26
  FDA Approved: LEVETIRACETAM — Supplemental Application (Method Pharmaceuticals, LLC)

  The FDA approved a supplemental application for levetiracetam by Method Pharmaceuticals, LLC.

• FDA approval · 2023-09-26
  FDA Approved: DIVALPROEX SODIUM — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original ANDA for divalproex sodium, providing a generic option for this anticonvulsant/mood stabilizer…

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• FDA approval · 2023-09-19
  FDA Approved: PHENYTOIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for phenytoin (Sun Pharmaceutical Industries, Inc.) under an ANDA, indicating an update to label…

• FDA approval · 2023-09-14
  FDA Approved: FINTEPLA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for FINTEPLA (fenfluramine) from UCB, Inc.; the approval updates the drug's labeling and/or indicati…

• FDA approval · 2023-09-13
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Tegretol (carbamazepine) filed by Novartis Pharmaceuticals Corporation.

• FDA approval · 2023-09-11
  FDA Approved: CLOBAZAM — Supplemental Application (Upsher-Smith Laboratories, LLC)

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

• FDA approval · 2023-09-11
  FDA Approved: ACETAZOLAMIDE — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s original application for acetazolamide (generic).

• FDA approval · 2023-08-31
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for KEPPRA (levetiracetam) submitted by UCB, Inc.

• FDA approval · 2023-08-31
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for Keppra (levetiracetam) from UCB, Inc., indicating an approved modification or expansion rela…

• FDA approval · 2023-08-31
  FDA Approved: LEVETIRACETAM — Supplemental Application (Prasco Laboratories)

  FDA indicates a Supplemental Application for Levetiracetam submitted by Prasco Laboratories; this represents an additional regulatory action…

• FDA approval · 2023-08-25
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for acetazolamide sodium filed by Mylan Institutional LLC, approving the salt form of acetazolamide …

• FDA approval · 2023-08-17
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Keppra (levetiracetam) from UCB, Inc. The approval indicates an update to the drug's labeling or…

• FDA approval · 2023-08-17
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Keppra (levetiracetam) submitted by UCB, Inc.

• FDA approval · 2023-08-17
  FDA Approved: KEPPRA XR — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for KEPPRA XR (levetiracetam) from UCB, Inc.

• FDA approval · 2023-08-16
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Eywa Pharma Inc)

  The FDA approved Eywa Pharma Inc's supplemental application for acetazolamide, enabling continued marketing of a generic acetazolamide produ…

• FDA approval · 2023-08-15
  FDA Approved: TOPIRAMATE — Original Application (Ajanta Pharma USA Inc.)

  The FDA approved Ajanta Pharma USA Inc.'s generic Topiramate through an Original Application (ANDA 215663). This approval provides a generic…

• FDA approval · 2023-08-08
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Breckenridge Pharmaceutical, Inc.)

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

• FDA approval · 2023-08-07
  FDA Approved: TOPIRAMATE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Topiramate submitted by Zydus Lifesciences Limited.

• FDA approval · 2023-08-07
  FDA Approved: GABAPENTIN — Supplemental Application (Ajenat Pharmaceuticals LLC)

  FDA approves a supplemental application for Gabapentin submitted by Ajenat Pharmaceuticals LLC.

• FDA approval · 2023-08-03
  FDA Approved: EXTENDED PHENYTOIN SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for Extended Phenytoin Sodium from Amneal Pharmaceuticals LLC.

• FDA approval · 2023-08-03
  FDA Approved: EXTENDED PHENYTOIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for an Extended Phenytoin Sodium product from Aurobindo Pharma Limited.

• FDA approval · 2023-08-03
  FDA Approved: ESLICARBAZEPINE ACETATE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' eslicarbazepine acetate as a generic, original-application product for adjunctive treatment of partial-…