Epilepsy

• FDA approval · 2022-12-27
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for divalproex sodium from Aurobindo Pharma Limited.

• FDA approval · 2022-12-02
  FDA Approved: CARBAMAZEPINE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approved the original application for a generic carbamazepine product from Ingenus Pharmaceuticals, LLC.

• FDA approval · 2022-11-30
  FDA Approved: OXCARBAZEPINE — Original Application (EPIC PHARMA, LLC)

  FDA approved a generic oxcarbazepine product from Epic Pharma through an Original Application (ANDA).

• FDA approval · 2022-11-28
  FDA Approved: TOPIRAMATE — Original Application (Zydus Lifesciences Limited)

  FDA approved Zydus Lifesciences Limited's Original Application for a generic Topiramate. Topiramate is used for epilepsy and migraine prophy…

• FDA approval · 2022-11-21
  FDA Approved: EPITOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for EPITOL (carbamazepine) from Teva Pharmaceuticals USA, Inc. This action approves changes to the p…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2022-11-21
  FDA Approved: TOPIRAMATE — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for Topiramate (generic Topiramate) from NorthStar RxLLC under an ANDA.

• 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 · 2022-11-16
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for divalproex sodium, authorizing changes to the approved generic product unde…

• FDA approval · 2022-11-15
  FDA Approved: LEVETIRACETAM — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved the original application for levetiracetam as a generic drug (Novadoz Pharmaceuticals LLC).

• FDA approval · 2022-11-10
  FDA Approved: DIAZEPAM — Original Application (Fresenius Kabi USA, LLC)

  The FDA approved Fresenius Kabi USA, LLC's Original Application for diazepam (generic diazepam). This approval adds a new generic option for…

• FDA approval · 2022-11-09
  FDA Approved: CARBAMAZEPINE — Supplemental Application (ANI Pharmaceuticals, Inc.)

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

• FDA approval · 2022-11-08
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Apotex Corp.)

  The FDA approved a supplemental application for Carbamazepine submitted by Apotex Corp., a generic formulation.

• FDA approval · 2022-11-08
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for carbamazepine from Apotex Corp., approving changes to the approved generic product.

• FDA approval · 2022-11-08
  FDA Approved: VIGABATRIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for Vigabatrin from Amneal Pharmaceuticals NY LLC, enabling a generic version of the drug.

• FDA approval · 2022-11-04
  FDA Approved: OXCARBAZEPINE — Original Application (Bionpharma Inc.)

  FDA approved the generic oxcarbazepine under an Original Application for Bionpharma Inc.

• FDA approval · 2022-11-01
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approves a supplemental application for oxcarbazepine submitted by Amneal Pharmaceuticals LLC for the generic product.

• FDA approval · 2022-10-28
  FDA Approved: VIGABATRIN — Supplemental Application (Cipla USA, Inc.)

  FDA approved a supplemental application for Vigabatrin submitted by Cipla USA, Inc., updating the product's labeling.

• FDA approval · 2022-10-26
  FDA Approved: RUFINAMIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's Rufinamide as a generic drug via an Original Application (ANDA 216549).

• FDA approval · 2022-10-25
  FDA Approved: VIGABATRIN FOR ORAL SOLUTION — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' supplemental application to market Vigabatrin as an oral solution, expanding the available dosage f…

• FDA approval · 2022-10-20
  FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Topamax (topiramate) submitted by Janssen Pharmaceuticals.

• FDA approval · 2022-10-13
  FDA Approved: PHENYTOIN SODIUM — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved the original ANDA for phenytoin sodium from Unichem Pharmaceuticals (USA), Inc., providing a generic version of the anticonvuls…

• FDA approval · 2022-10-12
  FDA Approved: VIGABATRIN — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved a supplemental application for Vigabatrin (VIGABATRIN) submitted by Zydus Pharmaceuticals (USA) Inc.

• FDA approval · 2022-10-12
  FDA Approved: VIGABATRIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for Vigabatrin by Amneal Pharmaceuticals NY LLC under ANDA210155, updating its regulatory status.

• FDA approval · 2022-10-12
  FDA Approved: VIGADRONE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for VIGADRONE (vigabatrin) from Upsher-Smith Laboratories, LLC, authorizing the continued marketing …

• FDA approval · 2022-10-12
  FDA Approved: VIGABATRIN — Supplemental Application (Cipla USA, Inc.)

  FDA approved a supplemental application for Vigabatrin by Cipla USA, Inc., under ANDA211592 (VIGABATRIN).