Partial-onset Seizures

• FDA approval · 2025-07-21
  FDA Approved: PREGABLIN — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for pregabalin from Macleods Pharmaceuticals Limited, authorizing a generic version of the drug. Thi…

• FDA approval · 2025-07-21
  FDA Approved: LACOSAMIDE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for lacosamide filed by Zydus Pharmaceuticals USA Inc., updating the product labeling. This action c…

• FDA approval · 2025-07-11
  FDA Approved: PERAMPANEL — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved the original ANDA for PERAMPANEL from Novadoz Pharmaceuticals LLC, making a generic version of perampanel available. This suppo…

• FDA approval · 2025-07-07
  FDA Approved: PREGABALIN — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approves a supplemental application for Pregabalin from Torrent Pharmaceuticals Limited, enabling the generic drug to be marketed.

• CLINICAL_TRIALS research · 2025-06-27
  Clinical Trial Update: A Study to Evaluate the Safety of Fycompa Injection in Participants With Partial-Onset Seizures or Primary Generalized Tonic- Clonic Seizures

  A clinical trial update describing a study to evaluate the safety of Fycompa Injection (perampanel) in participants with partial-onset seizu…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2025-06-26
  FDA Approved: LACOSAMIDE ORAL SOLUTION — Original Application (Ajenat Pharmaceuticals LLC)

  The FDA approved lacosamide oral solution under an original generic application (ANDA 219699) from Ajenat Pharmaceuticals LLC.

• CLINICAL_TRIALS research · 2025-06-03
  Clinical Trial Update: Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures [Phase 2]

  Phase 2 clinical trial update evaluating the safety of cenobamate in Japanese subjects with partial-onset seizures; the study (NCT06590896) …

• FDA approval · 2025-05-23
  FDA Approved: LACOSAMIDE — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals' lacosamide generic under Original Application (ANDA218706), expanding access to lacosamide for the…

• FDA approval · 2025-05-23
  FDA Approved: PERAMPANEL — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva Pharmaceuticals' original application for a generic version of perampanel. The product is manufactured by Teva Pharmaceuti…

• FDA approval · 2025-02-25
  FDA Approved: LEVETIRACETAM — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for an oral generic formulation of levetiracetam. This approval enables Camber…

• FDA approval · 2025-02-21
  FDA Approved: PREGABALIN — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved a generic pregabalin product from Torrent Pharmaceuticals Limited (ANDA 206942) to be used for the same indications as the refe…

• FDA approval · 2025-02-07
  FDA Approved: OXCARBAZEPINE — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for Oxcarbazepine by NorthStar RxLLC (ANDA216749).

• FDA approval · 2025-02-07
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for oxcarbazepine from Amneal Pharmaceuticals LLC under ANDA202961.

• FDA approval · 2025-02-05
  FDA Approved: LEVETIRACETAM — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application from BluePoint Laboratories for levetiracetam, authorizing approval of a generic version of the anti…

• FDA approval · 2024-12-27
  FDA Approved: GABAPENTIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for gabapentin from Rising Pharma Holdings, Inc. The snippet does not specify the exact scope (e.g.,…

• FDA approval · 2024-12-23
  FDA Approved: PREGABALIN — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for pregabalin filed by Chartwell RX, LLC (ANDA212865).

• FDA approval · 2024-12-19
  FDA Approved: PREGABALIN — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' supplemental application for pregabalin (generic pregabalin).

• FDA approval · 2024-12-12
  FDA Approved: PREGABALIN — Supplemental Application (Advagen Pharma Ltd.)

  FDA approved the supplemental application for pregabalin from Advagen Pharma Ltd., authorizing the generic product under an ANDA.

• 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 · 2024-11-15
  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 · 2024-11-14
  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 · 2024-10-09
  FDA Approved: LACOSAMIDE — Original Application (Somerset Therapeutics, LLC)

  FDA approved the original application for lacosamide by Somerset Therapeutics, LLC, approving a generic version of the anticonvulsant.

• FDA approval · 2024-09-04
  FDA Approved: LACOSAMIDE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approves Unichem Pharmaceuticals' original application for lacosamide, enabling a generic version of the seizure medication. The approva…

• FDA approval · 2024-08-28
  FDA Approved: PREGABALIN — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for pregabalin.