Epilepsy

• FDA approval · 2023-08-02
  FDA Approved: GABAPENTIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approves a supplemental application for Gabapentin submitted by Amneal Pharmaceuticals LLC.

• FDA approval · 2023-07-31
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for divalproex sodium by Lupin Pharmaceuticals, Inc. under ANDA 078790.

• FDA approval · 2023-07-28
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for divalproex sodium submitted by BluePoint Laboratories, associated with an existing ANDA.

• FDA approval · 2023-07-28
  FDA Approved: LAMOTRIGINE — Supplemental Application (Dr. Reddys Laboratories Inc.)

  FDA approved a supplemental application for lamotrigine from Dr. Reddy's Laboratories Inc., under the ANDA process.

• FDA approval · 2023-07-21
  FDA Approved: LACOSAMIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for lacosamide from ANI Pharmaceuticals, Inc., under ANDA 216151.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2023-07-19
  FDA Approved: GABAPENTIN — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved a generic gabapentin product from Rising Pharma Holdings, Inc. under an Original Application (ANDA217995).

• FDA approval · 2023-07-17
  FDA Approved: TOPIRAMATE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' supplemental application for Topiramate (generic).

• FDA approval · 2023-07-13
  FDA Approved: OXCARBAZEPINE — Original Application (Apotex Corp.)

  The FDA approved Apotex Corp.'s generic oxcarbazepine under an Original Application (ANDA 213369). This approval makes the generic oxcarbaze…

• FDA approval · 2023-07-12
  FDA Approved: LACOSAMIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for lacosamide, a generic antiseizure medication used as adjunctive therapy fo…

• FDA approval · 2023-07-10
  FDA Approved: DIAZEPAM — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application for Diazepam from Oceanside Pharmaceuticals.

• FDA approval · 2023-07-03
  FDA Approved: OXCARBAZEPINE — Original Application (Zydus Lifesciences Limited)

  FDA approved the Original Application for Oxcarbazepine from Zydus Lifesciences Limited, providing a generic option for the treatment of epi…

• FDA approval · 2023-06-16
  FDA Approved: LEVETIRACETAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for levetiracetam, enabling the marketing of a generic version of the drug.…

• FDA approval · 2023-06-16
  FDA Approved: RUFINAMIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's original ANDA for a generic Rufinamide product, intended for seizures associated with Lennox-Gastaut…

• FDA approval · 2023-06-13
  FDA Approved: LEVETIRACETAM — Original Application (Granules Pharmaceuticals Inc.)

  FDA approved a generic version of levetiracetam from Granules Pharmaceuticals Inc. under an original ANDA (ANDA217878), expanding access to …

• FDA approval · 2023-06-08
  FDA Approved: LAMOTRIGINE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for Lamotrigine from Unichem Pharmaceuticals (USA), Inc.

• FDA approval · 2023-05-26
  FDA Approved: LEVETIRACETAM — Supplemental Application (Civica, Inc.)

  The FDA approved Civica, Inc.'s supplemental application for levetiracetam (generic).

• FDA approval · 2023-05-23
  FDA Approved: LEVETIRACETAM — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental application to authorize Levetiracetam in sodium chloride for intravenous use, manufactured by Eugia US LLC.

• FDA approval · 2023-05-23
  FDA Approved: LEVETIRACETAM — Supplemental Application (Dr.Reddy's Laboratories Inc)

  FDA approved a supplemental application for LEVETIRACETAM injection from Dr. Reddy's Laboratories.

• FDA approval · 2023-05-22
  FDA Approved: LEVETIRACETAM — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental application for levetiracetam filed by Eugia US LLC.

• FDA approval · 2023-05-22
  FDA Approved: CLOBAZAM — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for CLOBAZAM (clobazam) from Amneal Pharmaceuticals NY LLC, updating the approval of this generic pr…

• FDA approval · 2023-05-22
  FDA Approved: LEVETIRACETAM — Supplemental Application (Major Pharmaceuticals)

  FDA supplemental application approval for levetiracetam (Major Pharmaceuticals) under ANDA201157.

• FDA approval · 2023-05-22
  FDA Approved: LEVETIRACETAM — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for LEVETIRACETAM from Micro Labs Limited (ANDA211954).

• FDA approval · 2023-05-19
  FDA Approved: LEVETIRACETAM SOLUTION — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for LEVETIRACETAM SOLUTION, adding a new solution dosage form of levetiracetam for Chartwell RX,…

• FDA approval · 2023-05-19
  FDA Approved: LEVETIRACETAM — Supplemental Application (Amneal Pharmaceuticals LLC)

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

• FDA approval · 2023-05-17
  FDA Approved: BRIVIACT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Briviact (brivaracetam) from UCB, Inc., updating the labeling following regulatory review.