Epilepsy

• FDA approval · 2025-02-28
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for oxcarbazepine from Ascend Laboratories, LLC.

• FDA approval · 2025-02-26
  FDA Approved: TOPIRAMATE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for Topiramate by Ascend Laboratories, LLC (ANDA 217795), resulting in an updated regulatory action …

• 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…

• FDA approval · 2025-02-21
  FDA Approved: LEVETIRACETAM — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for LEVETIRACETAM from Ascend Laboratories, LLC under an ANDA, indicating an approved change to an e…

• FDA approval · 2025-02-21
  FDA Approved: LEVETIRACETAM — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental application for the generic levetiracetam product from Eugia US LLC under an ANDA.

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• FDA approval · 2025-02-21
  FDA Approved: LEVETIRACETAM — Supplemental Application (Prinston Pharmaceutical Inc.)

  FDA approved a supplemental application for a generic version of levetiracetam from Prinston Pharmaceutical Inc.

• FDA approval · 2025-02-14
  FDA Approved: LEVETIRACETAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for levetiracetam from Lupin Pharmaceuticals, expanding/modifying the labeling for this product.…

• FDA approval · 2025-02-14
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for oxcarbazepine from Bionpharma Inc., granting additional authorization under ANDA 209652.

• FDA approval · 2025-02-14
  FDA Approved: LEVETIRACETAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for levetiracetam, updating the product's labeling/indications.

• FDA approval · 2025-02-10
  FDA Approved: LEVETIRACETAM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approves a supplemental application for levetiracetam from Mylan Pharmaceuticals Inc., resulting in approval of a generic product. This …

• FDA approval · 2025-02-10
  FDA Approved: LEVETIRACETAM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Levetiracetam submitted by Mylan Pharmaceuticals Inc.

• FDA approval · 2025-02-07
  FDA Approved: OXCARBAZEPINE — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for Oxcarbazepine by NorthStar RxLLC (ANDA216749).

• FDA approval · 2025-02-07
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for oxcarbazepine from Amneal Pharmaceuticals LLC under ANDA202961.

• FDA approval · 2025-02-05
  FDA Approved: LEVETIRACETAM — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application from BluePoint Laboratories for levetiracetam, authorizing approval of a generic version of the anti…

• FDA approval · 2025-02-05
  FDA Approved: LEVETIRACETAM — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved Torrent Pharmaceuticals Limited's supplemental application for levetiracetam, approving its generic product under an ANDA. …

• FDA approval · 2025-01-29
  FDA Approved: BRIVARACETAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for BRIVARACETAM from Aurobindo Pharma Limited under an ANDA.

• FDA approval · 2025-01-27
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for Acetazolamide from Accord Healthcare Inc. under an Abbreviated New Drug Application.

• FDA approval · 2025-01-27
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Carbamazepine from Torrent Pharmaceuticals Limited under an ANDA.

• FDA approval · 2025-01-23
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote ER (divalproex sodium) submitted by AbbVie Inc.

• FDA approval · 2025-01-16
  FDA Approved: LEVETIRACETAM — Original Application (Somerset Therapeutics, LLC)

  FDA approved Somerset Therapeutics, LLC's original abbreviated new drug application for levetiracetam in sodium chloride, a generic formulat…

• FDA approval · 2025-01-14
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Ingenus Pharmaceuticals, LLC)

  FDA approved a supplemental application for a generic Carbamazepine product from Ingenus Pharmaceuticals, LLC.

• FDA approval · 2025-01-14
  FDA Approved: CARBAMAZEPINE — Original Application (Ascend Laboratories, LLC)

  FDA approved a generic carbamazepine product from Ascend Laboratories, LLC under an Original Application (ANDA).

• FDA approval · 2025-01-13
  FDA Approved: CARBAMAZEPINE — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's original application for a generic carbamazepine product.

• FDA approval · 2025-01-08
  FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for lamotrigine from Zydus Pharmaceuticals USA Inc. under an ANDA, indicating an approved change…

• FDA approval · 2024-12-31
  FDA Approved: GABAPENTIN — Supplemental Application (ScieGen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for gabapentin by ScieGen Pharmaceuticals, Inc.