Seizure Disorders

• FDA approval · 2026-08-10
  FDA Approved: BRIVARACETAM — Original Application (Aurobindo Pharma Limited)

  FDA approval overview for the generic anticonvulsant brivaracetam marketed by Aurobindo Pharma Limited.

• FDA approval · 2026-04-08
  FDA Approved: LEVETIRACETAM SOLUTION — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for LEVETIRACETAM SOLUTION from Chartwell RX, LLC, granting approval under the ANDA process.

• FDA approval · 2025-11-14
  FDA Approved: DIAZEPAM — Original Application (Navinta LLC)

  FDA approved Navinta LLC's generic diazepam through an Original Application (ANDA 217468).

• FDA approval · 2025-03-05
  FDA Approved: LEVETIRACETAM IN SODIUM CHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for levetiracetam in sodium chloride, a new injectable formulation by Hikma Pharmaceuticals USA Inc.…

• FDA approval · 2025-02-25
  FDA Approved: LEVETIRACETAM — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for an oral generic formulation of levetiracetam. This approval enables Camber…

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• FDA approval · 2024-12-17
  FDA Approved: DIAZEPAM — Supplemental Application (Lupin Pharmaceuticals,Inc.)

  FDA approved a supplemental application for diazepam submitted by Lupin Pharmaceuticals, Inc. The approval relates to changes under the appr…

• FDA approval · 2024-12-16
  FDA Approved: DIAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for diazepam from Hikma Pharmaceuticals USA Inc., updating the approval status of this generic produ…

• FDA approval · 2024-10-17
  FDA Approved: CLORAZEPATE DIPOTASSIUM — Supplemental Application (NORTHSTAR RX LLC)

  FDA approved a supplemental application for clorazepate dipotassium submitted by NorthStar RX LLC.

• FDA approval · 2024-07-05
  FDA Approved: LEVETIRACETAM — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for Levetiracetam from Micro Labs Limited.

• FDA approval · 2024-04-24
  FDA Approved: LACOSAMIDE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for lacosamide submitted by Ascend Laboratories, LLC, signaling a regulatory action on this generic …

• FDA approval · 2024-01-23
  FDA Approved: PRIMIDONE — Original Application (Carnegie Pharmaceuticals LLC)

  FDA approved the original ANDA for primidone from Carnegie Pharmaceuticals LLC. Primidone is an anticonvulsant used in the treatment of cert…

• 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…

• FDA approval · 2023-09-25
  FDA Approved: LORAZEPAM — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for lorazepam submitted by Hospira, Inc. under ANDA 074243.

• FDA approval · 2023-05-23
  FDA Approved: LEVETIRACETAM — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental application to authorize Levetiracetam in sodium chloride for intravenous use, manufactured by Eugia US LLC.

• FDA approval · 2023-05-22
  FDA Approved: LEVETIRACETAM — Supplemental Application (Major Pharmaceuticals)

  FDA supplemental application approval for levetiracetam (Major Pharmaceuticals) under ANDA201157.

• FDA approval · 2023-03-01
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for oxcarbazepine filed by Amneal Pharmaceuticals LLC.

• FDA approval · 2023-02-08
  FDA Approved: DIAZEPAM — Supplemental Application (Natco Pharma USA LLC)

  FDA approves a supplemental application for Diazepam by Natco Pharma USA LLC, approving a supplemental change to the generic diazepam produc…

• FDA approval · 2023-01-17
  FDA Approved: DIAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Diazepam from Hikma Pharmaceuticals USA Inc., indicating an update to an existing Diazepam produ…

• FDA approval · 2023-01-13
  FDA Approved: VALIUM — Supplemental Application (Roche Laboratories Inc.)

  The FDA approved a supplemental application for Valium (diazepam) from Roche Laboratories Inc., updating the existing NDA.

• FDA approval · 2022-11-17
  FDA Approved: SEZABY — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved SEZABY (phenobarbital sodium) from Sun Pharmaceutical Industries via an original NDA. It is an anticonvulsant indicated for sei…

• FDA approval · 2022-05-27
  FDA Approved: LEVETIRACETAM — Original Application (ScieGen Pharmaceuticals, Inc.)

  The FDA approved an original Abbreviated New Drug Application (ANDA) for Levetiracetam from ScieGen Pharmaceuticals, establishing a generic …

• FDA approval · 2021-06-08
  FDA Approved: LEVETIRACETAM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's supplemental application for levetiracetam (generic).

• FDA approval · 2021-02-16
  FDA Approved: PHENYTOIN SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Phenytoin Sodium from Hikma Pharmaceuticals USA Inc.

• FDA approval · 2021-02-08
  FDA Approved: DIAZEPAM — Supplemental Application (Natco Pharma USA LLC)

  FDA approved a supplemental application for Diazepam from Natco Pharma USA LLC (ANDA 211998). This action confirms the continued approval/av…

• FDA approval · 2021-02-05
  FDA Approved: DIAZEPAM INTENSOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Diazepam Intensol from Hikma Pharmaceuticals USA Inc.