Partial-onset Seizures

• 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).

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• 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.

• FDA approval · 2024-08-26
  FDA Approved: LEVETIRACETAM ER — Supplemental Application (Westminster Pharmaceuticals, LLC)

  The FDA approved Westminster Pharmaceuticals' supplemental application to authorize the levetiracetam extended-release formulation (LEVETIRA…

• FDA approval · 2024-08-23
  FDA Approved: PREGABALIN — Supplemental Application (Solco Healthcare US, LLC)

  FDA approved a supplemental application for pregabalin from Solco Healthcare US, LLC, granting approval for changes related to the generic p…

• FDA approval · 2024-08-14
  FDA Approved: OXTELLAR XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)

  FDA approved a supplemental application for OXTELLAR XR (oxcarbazepine) from Supernus Pharmaceuticals, expanding its approved labeling.

• FDA approval · 2024-07-11
  FDA Approved: PREGABALIN — Supplemental Application (ScieGen Pharmaceuticals, Inc)

  FDA approved ScieGen Pharmaceuticals' generic pregabalin product through an abbreviated new drug application.

• FDA approval · 2024-07-05
  FDA Approved: LEVETIRACETAM — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for Levetiracetam from Micro Labs Limited.

• FDA approval · 2024-06-20
  FDA Approved: APTIOM — Supplemental Application (Sumitomo Pharma America, Inc.)

  FDA approves a supplemental application for APTIOM (eslicarbazepine acetate) submitted by Sumitomo Pharma America, Inc.

• FDA approval · 2024-06-05
  FDA Approved: PREGABALIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves the supplemental ANDA for pregabalin from Aurobindo Pharma Limited, enabling the marketing of a generic pregabalin product in t…