Epilepsy

• FDA approval · 2024-03-18
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA approved AbbVie's supplemental application for Depakote Sprinkles (divalproex sodium).

• FDA approval · 2024-03-18
  FDA Approved: OXCARBAZEPINE — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories, LLC's original ANDA for oxcarbazepine (generic), a seizure medication used to treat epilepsy.

• FDA approval · 2024-03-12
  FDA Approved: KEPPRA XR — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for KEPPRA XR (levetiracetam) from UCB, Inc., related to the extended-release formulation.

• FDA approval · 2024-03-12
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for KEPPRA (levetiracetam) from UCB, Inc. The approval updates the product labeling.

• FDA approval · 2024-03-12
  FDA Approved: LEVETIRACETAM — Supplemental Application (WG Critical Care, LLC)

  FDA approves a supplemental application for levetiracetam submitted by WG Critical Care, LLC.

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• FDA approval · 2024-03-12
  FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for ONFI (clobazam) from Lundbeck Pharmaceuticals LLC.

• FDA approval · 2024-03-12
  FDA Approved: LEVETIRACETAM — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Levetiracetam filed by Prasco Laboratories.

• FDA approval · 2024-03-12
  FDA Approved: ELEPSIA XR 1000 MG — Supplemental Application (TRIPOINT THERAPEUTICS, LLC)

  FDA approved a supplemental application for ELEPSIA XR 1000 mg (levetiracetam) from Tripoint Therapeutics, LLC.

• FDA approval · 2024-03-05
  FDA Approved: OXCARBAZEPINE — Original Application (Advagen Pharma Ltd.)

  FDA approved the original application for oxcarbazepine by Advagen Pharma Ltd., enabling the generic product to be marketed.

• FDA approval · 2024-03-01
  FDA Approved: OXCARBAZEPINE — Original Application (Biocon Pharma Inc.)

  FDA approved Biocon Pharma Inc.'s oxcarbazepine as an Original Application (ANDA) generic. The drug is indicated for the treatment of partia…

• CLINICAL_TRIALS trial_result · 2024-02-28
  Clinical Trial Update: Fenfluramine for the Treatment of Different Types of Developmental and Epileptic Encephalopathies: a Pilot Trial Exploring Epileptic and Non-epileptic Outcomes [Phase 4]

  Pilot Phase 4 trial evaluating fenfluramine for various developmental and epileptic encephalopathies, including SYNGAP1 and STXBP1-related c…

• FDA approval · 2024-02-27
  FDA Approved: ESLICARBAZEPINE ACETATE — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved eslicarbazepine acetate from Torrent Pharmaceuticals Limited under an original ANDA application.

• FDA approval · 2024-02-27
  FDA Approved: LEVETIRACETAM — Original Application (B. Braun Medical Inc.)

  FDA approved the generic levetiracetam from B. Braun Medical Inc. under an original ANDA.

• FDA approval · 2024-02-26
  FDA Approved: GABAPENTIN — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approval of Gabapentin in an original application for Camber Pharmaceuticals, establishing a generic version of Gabapentin.

• FDA approval · 2024-02-26
  FDA Approved: GABAPENTIN — Original Application (Epic Pharma, LLC)

  FDA approved the original application for gabapentin from Epic Pharma, LLC, introducing a generic gabapentin product to the market.

• FDA approval · 2024-02-22
  FDA Approved: OXCARBAZEPINE — Original Application (Ajanta Pharma USA Inc.)

  The FDA approved Ajanta Pharma USA Inc.'s generic oxcarbazepine through an original application. It is indicated for the treatment of partia…

• FDA approval · 2024-02-20
  FDA Approved: GABAPENTIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for gabapentin from Rising Pharma Holdings, Inc., authorizing changes to the approved generic produc…

• FDA approval · 2024-02-14
  FDA Approved: OXCARBAZEPINE — Original Application (Kanchan Healthcare Inc)

  FDA approves the generic oxcarbazepine under an original application by Kanchan Healthcare Inc.

• FDA approval · 2024-02-13
  FDA Approved: LACOSAMIDE — Original Application (Sintetica US LLC)

  FDA approves a lacosamide generic product from Sintetica US LLC under Original Application (ANDA 217311).

• FDA approval · 2024-02-12
  FDA Approved: LEVETIRACETAM IN SODIUM CHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s generic levetiracetam in sodium chloride injection under an Original Application.

• CLINICAL_TRIALS trial_result · 2024-02-07
  Clinical Trial Update: Pharmacokinetics Study of Oral 2-Deoxy-D-Glucose (2DG) in Subjects With a Confirmed Diagnosis of Epilepsy [Phase 2]

  Phase 2 pharmacokinetics study of oral 2-Deoxy-D-Glucose (2DG) in adults with epilepsy has completed.

• FDA approval · 2024-02-01
  FDA Approved: PHENYTEK — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for PHENYTEK (extended phenytoin sodium) from Mylan Pharmaceuticals Inc.

• FDA approval · 2024-01-29
  FDA Approved: CARBAMAZEPINE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for carbamazepine submitted by ANI Pharmaceuticals, Inc.

• FDA approval · 2024-01-29
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application to permit Chartwell RX, LLC to market a generic carbamazepine product under an ANDA.

• FDA approval · 2024-01-29
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved a supplemental application for carbamazepine from Zydus Pharmaceuticals (USA) Inc., updating the approved generic product.