Epilepsy

• FDA approval · 2021-06-21
  FDA Approved: OXCARBAZEPINE — Original Application (Chartwell RX, LLC)

  FDA approves Chartwell RX, LLC's original generic oxcarbazepine for treatment of partial seizures in adults and children with epilepsy.

• FDA approval · 2021-06-11
  FDA Approved: LEVETIRACETAM — Original Application (ScieGen Pharmaceuticals, Inc.)

  FDA approved the original application (ANDA) for LEVETIRACETAM by ScieGen Pharmaceuticals, authorizing the generic product.

• 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 · 2021-05-17
  FDA Approved: DIAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for diazepam filed by Hikma Pharmaceuticals USA Inc., marking regulatory clearance for an additi…

• FDA approval · 2021-05-11
  FDA Approved: RUFINAMIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' generic Rufinamide (ANDA 204993) for the treatment of seizures associated with Lennox-Gastaut syndrome,…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2021-04-26
  FDA Approved: GABAPENTIN — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Gabapentin from Actavis Pharma, Inc., enabling the generic product to reach the market.

• FDA approval · 2021-04-23
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for divalproex sodium from Aurobindo Pharma Limited, a generic formulation.

• FDA approval · 2021-04-13
  FDA Approved: CARBAMAZEPINE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved Upsher-Smith Laboratories' Original Application for carbamazepine (generic) under ANDA213311.

• FDA approval · 2021-04-05
  FDA Approved: LEVETIRACETAM — Supplemental Application (Hisun Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for LEVETIRACETAM from Hisun Pharmaceuticals USA, Inc., resulting in approval of a generic version o…

• FDA approval · 2021-03-31
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for LAMICTAL ODT (lamotrigine) submitted by GlaxoSmithKline, updating its regulatory status for …

• FDA approval · 2021-03-25
  FDA Approved: DIAZEPAM — Supplemental Application (Oceanside Pharmaceuticals)

  FDA supplemental approval for Diazepam under Oceanside Pharmaceuticals is recorded, confirming the approval of a supplemental application fo…

• FDA approval · 2021-03-16
  FDA Approved: SYMPAZAN — Supplemental Application (Aquestive Therapeutics)

  FDA approved a supplemental application for Sympazan (clobazam) by Aquestive Therapeutics. The action updates the product labeling (and rela…

• FDA approval · 2021-03-10
  FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Lamotrigine from Zydus Pharmaceuticals USA Inc., indicating an update to its labeling/indica…

• FDA approval · 2021-03-05
  FDA Approved: GABAPENTIN — Supplemental Application (Granules Pharmaceuticals Inc)

  FDA approved Granules Pharmaceuticals Inc's supplemental application for gabapentin granules, approving a new granulated formulation of a ge…

• FDA approval · 2021-02-23
  FDA Approved: FYCOMPA — Supplemental Application (Eisai Inc.)

  The FDA approved a supplemental application for FYCOMPA (perampanel) submitted by Eisai Inc.

• FDA approval · 2021-02-22
  FDA Approved: ACETAZOLAMIDE — Original Application (TRUPHARMA, LLC)

  The FDA approved an original ANDA for Acetazolamide, a generic version manufactured by TRUPHARMA, LLC.

• FDA approval · 2021-02-17
  FDA Approved: FOSPHENYTOIN SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for fosphenytoin sodium submitted by Amneal Pharmaceuticals LLC, signaling an updated approval f…

• FDA approval · 2021-02-16
  FDA Approved: PHENYTOIN SODIUM — Supplemental Application (Acella Pharmaceuticals, LLC)

  The FDA has approved Acella Pharmaceuticals' supplemental application for phenytoin sodium. This action pertains to their generic anti-seizu…

• FDA approval · 2021-02-16
  FDA Approved: DILANTIN-125 — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for DILANTIN-125 (PHENYTOIN) by Viatris Specialty LLC.

• 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 · 2021-02-10
  FDA Approved: DEPAKOTE — Supplemental Application (AbbVie Inc.)

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

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

  FDA approved a supplemental application for Diazepam (generic) from Natco Pharma USA LLC under an ANDA. The action confirms approval of the …

• 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.

• FDA approval · 2021-02-05
  FDA Approved: SYMPAZAN — Supplemental Application (Aquestive Therapeutics)

  FDA approved a supplemental application for Sympazan (clobazam) from Aquestive Therapeutics.

• FDA approval · 2021-02-05
  FDA Approved: NAYZILAM — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Nayzilam (midazolam) by UCB, expanding its approved use/labeling. This action formalizes updated…