Epilepsy

• FDA approval · 2024-01-04
  FDA Approved: TOPIRAMATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Topiramate from Aurobindo Pharma Limited under an ANDA for an already approved generic product.

• FDA approval · 2023-12-27
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Aurobindo Pharma Limited)

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

• FDA approval · 2023-12-22
  FDA Approved: CARBAMAZEPINE — Supplemental Application (NIVAGEN PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for Carbamazepine from NIVAGEN Pharmaceuticals, authorizing changes to the generic product under the…

• FDA approval · 2023-12-22
  FDA Approved: LACOSAMIDE — Original Application (Glenmark Pharmaceuticals Limited)

  FDA approved Glenmark's lacosamide generic drug under an Original Application (ANDA 215379). Lacosamide is indicated as adjunctive therapy f…

• FDA approval · 2023-12-11
  FDA Approved: FINTEPLA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for FINTEPLA (fenfluramine) filed by UCB, Inc., expanding/adjusting its labeling and indications.

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• FDA approval · 2023-12-11
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for carbamazepine filed by Unichem Pharmaceuticals (USA), Inc., signaling an approved change to …

• FDA approval · 2023-12-07
  FDA Approved: ESLICARBAZEPINE ACETATE — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s original ANDA for eslicarbazepine acetate, a generic anticonvulsant, for use as adjunctive therapy in adults wit…

• FDA approval · 2023-12-05
  FDA Approved: TOPIRAMATE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approves an original abbreviated application for Topiramate from Upsher-Smith Laboratories, establishing a generic formulation of the an…

• FDA approval · 2023-11-22
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for divalproex sodium submitted by Bionpharma Inc. under an ANDA.

• FDA approval · 2023-11-22
  FDA Approved: DIAZEPAM — Supplemental Application (Sunrise Pharmaceutical, Inc.)

  The FDA approved a supplemental application for Diazepam submitted by Sunrise Pharmaceutical, Inc.

• FDA approval · 2023-11-21
  FDA Approved: LEVETIRACETAM — Supplemental Application (Major Pharmaceuticals)

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

• FDA approval · 2023-11-17
  FDA Approved: TOPIRAMATE — Original Application (Dr. Reddys Laboratories Inc.)

  FDA approves a generic version of Topiramate from Dr. Reddy's Laboratories Inc. through an Original Application (ANDA).

• FDA approval · 2023-11-16
  FDA Approved: LEVETIRACETAM — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for levetiracetam from Fresenius Kabi USA, LLC under an ANDA.

• FDA approval · 2023-11-13
  FDA Approved: LACOSAMIDE — Original Application (Apotex Corp)

  FDA approved Apotex Corp's original ANDA for lacosamide, authorizing a generic version of the anticonvulsant used to treat partial-onset sei…

• FDA approval · 2023-10-24
  FDA Approved: LEVETIRACETAM — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for levetiracetam from Amneal Pharmaceuticals LLC.

• FDA approval · 2023-10-23
  FDA Approved: LEVETIRACETAM — Supplemental Application (Hisun Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for levetiracetam from Hisun Pharmaceuticals USA, Inc., resulting in approval of a generic produ…

• FDA approval · 2023-10-23
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for divalproex sodium from Mylan Pharmaceuticals, indicating regulatory authorization for a generic …

• FDA approval · 2023-10-20
  FDA Approved: OXCARBAZEPINE — Original Application (NorthStar RxLLC)

  The FDA approved NorthStar RxLLC's original application for oxcarbazepine, a generic antiepileptic drug, for the treatment of partial-onset …

• FDA approval · 2023-10-16
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Vimpat (lacosamide) submitted by UCB, Inc., resulting in updated labeling for the product.

• FDA approval · 2023-10-16
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for VIMPAT (lacosamide) submitted by UCB, Inc. The approval confirms the sponsor's supplemental …

• FDA approval · 2023-10-13
  FDA Approved: FOSPHENYTOIN SODIUM — Original Application (Sagent Pharmaceuticals)

  FDA approved an original generic application for fosphenytoin sodium, enabling a generic version of this anticonvulsant to be marketed by Sa…

• FDA approval · 2023-10-11
  FDA Approved: VALIUM — Supplemental Application (Roche Laboratories Inc.)

  FDA approved a Supplemental Application for Valium (diazepam) from Roche Laboratories Inc., indicating an approved change or addition to the…

• FDA approval · 2023-10-11
  FDA Approved: VIGABATRIN — Supplemental Application (Par Health USA, LLC)

  FDA approved a supplemental application for Vigabatrin by Par Health USA, LLC.

• FDA approval · 2023-10-06
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for divalproex sodium from Sun Pharmaceutical Industries, Inc.

• FDA approval · 2023-10-06
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for divalproex sodium from Upsher-Smith Laboratories, LLC.