Epilepsy

• FDA approval · 2024-12-26
  FDA Approved: LAMOTRIGINE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for lamotrigine by Amneal Pharmaceuticals LLC (ANDA 207497).

• FDA approval · 2024-12-19
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals, Inc.'s supplemental application for Oxcarbazepine.

• FDA approval · 2024-12-17
  FDA Approved: LEVETIRACETAM — Supplemental Application (SOHM, Inc.)

  The FDA approved a supplemental application for LEVETIRACETAM submitted by SOHM, Inc.

• FDA approval · 2024-12-10
  FDA Approved: GABAPENTIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for gabapentin from Amneal Pharmaceuticals LLC to modify an existing gabapentin product.

• FDA approval · 2024-12-05
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for divalproex sodium submitted by Unichem Pharmaceuticals (USA), Inc. under ANDA079163. This ac…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2024-12-02
  FDA Approved: GABAPENTIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for gabapentin from Sun Pharmaceutical Industries, Inc., authorizing a modification to the approved …

• FDA approval · 2024-11-26
  FDA Approved: ACETAZOLAMIDE EXTENDED-RELEASE — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application from Micro Labs Limited for an extended-release formulation of acetazolamide.

• FDA approval · 2024-11-26
  FDA Approved: TOPIRAMATE — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for Topiramate submitted by NorthStar RxLLC.

• FDA approval · 2024-11-22
  FDA Approved: OXCARBAZEPINE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approved the original application for a generic oxcarbazepine product from Ingenus Pharmaceuticals, enabling marketing of the generic an…

• FDA approval · 2024-11-21
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved a supplemental application for oxcarbazepine filed by Ajanta Pharma USA Inc., approving changes related to the marketed product…

• FDA approval · 2024-11-18
  FDA Approved: LORAZEPAM — Original Application (Fresenius Kabi USA, LLC)

  FDA approved the Original Application for lorazepam from Fresenius Kabi USA, LLC, granting a generic version of the drug.

• FDA approval · 2024-11-15
  FDA Approved: LACOSAMIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's supplemental application for lacosamide, enabling the generic lacosamide product to enter the U.S. m…

• FDA approval · 2024-11-15
  FDA Approved: LACOSAMIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for lacosamide from Aurobindo Pharma Limited, enabling the marketing of a generic lacosamide product…

• FDA approval · 2024-11-15
  FDA Approved: LACOSAMIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for lacosamide from Sun Pharmaceutical Industries, Inc. to modify the approved generic lacosamid…

• FDA approval · 2024-11-14
  FDA Approved: LEVETIRACETAM — Supplemental Application (Hisun Pharmaceuticals USA, Inc.)

  FDA granted a supplemental approval for Levetiracetam from Hisun Pharmaceuticals USA, Inc. to bring a generic product to market (ANDA207175)…

• FDA approval · 2024-11-14
  FDA Approved: LACOSAMIDE — Original Application (Trigen Laboratories, LLC)

  FDA approved Trigen Laboratories, LLC's original application for lacosamide, enabling a generic lacosamide product to enter the market.

• FDA approval · 2024-11-13
  FDA Approved: LEVETIRACETAM — Supplemental Application (Major Pharmaceuticals)

  The FDA approved a supplemental application for levetiracetam from Major Pharmaceuticals (ANDA201157).

• FDA approval · 2024-11-13
  FDA Approved: LEVETIRACETAM — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for LEVETIRACETAM submitted by NorthStar RxLLC.

• EMA approval · 2024-11-13
  EMA Authorised: Buccolam (midazolam) — Neuraxpharm Pharmaceuticals S.L.

  The EMA authorised Buccolam, a midazolam product, for treatment of epileptic seizures; the marketing authorization holder is Neuraxpharm Pha…

• FDA approval · 2024-11-05
  FDA Approved: TOPIRAMATE — Original Application (Vitruvias Therapeutics, Inc.)

  FDA approves Vitruvias Therapeutics' generic Topiramate through an Original Application (ANDA), expanding access as a generic option for epi…

• FDA approval · 2024-10-31
  FDA Approved: TOPIRAMATE — Original Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' original ANDA for topiramate, providing a generic version of this anticonvulsant and migraine preventi…

• FDA approval · 2024-10-23
  FDA Approved: TOPIRAMATE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Topiramate from Zydus Lifesciences Limited under an ANDA.

• FDA approval · 2024-10-15
  FDA Approved: GABAPENTIN — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for gabapentin filed by Aurobindo Pharma Limited. This action approves a generic formulation of …

• FDA approval · 2024-10-09
  FDA Approved: LAMOTRIGINE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for lamotrigine from Ascend Laboratories, granting approval for a generic lamotrigine product.

• FDA approval · 2024-10-09
  FDA Approved: LEVETIRACETAM — Supplemental Application (Apotex Corp.)

  The FDA approved Apotex Corp.'s supplemental application to market a generic version of levetiracetam.