Partial-onset Seizures

• 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.

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• 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…

• FDA approval · 2024-06-04
  FDA Approved: BRIVARACETAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for brivaracetam from Aurobindo Pharma Limited. This enables the marketing of a generic brivaracetam…

• FDA approval · 2024-05-24
  FDA Approved: LACOSAMIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved a lacosamide generic from Macleods Pharmaceuticals Limited under an Original Application (ANDA 208466).

• FDA approval · 2024-05-15
  FDA Approved: LACOSAMIDE ORAL SOLUTION — Original Application (Chartwell RX, LLC)

  FDA approved a generic lacosamide oral solution from Chartwell RX, LLC under an original ANDA. Lacosamide is used as adjunctive therapy for …

• CLINICAL_TRIALS trial_result · 2024-05-14
  Clinical Trial Update: Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures [Phase 3]

  This update reports the completion of a Phase 3 safety and pharmacokinetic study of cenobamate (YKP3089) as adjunctive therapy for partial o…

• FDA approval · 2024-04-24
  FDA Approved: LACOSAMIDE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for lacosamide submitted by Ascend Laboratories, LLC, signaling a regulatory action on this generic …

• FDA approval · 2024-04-23
  FDA Approved: LEVETIRACETAM — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for levetiracetam submitted by Apotex Corp., under ANDA 202958.

• FDA approval · 2024-04-02
  FDA Approved: LACOSAMIDE — Original Application (Kanchan Healthcare Inc)

  FDA approved an Original Application for Lacosamide by Kanchan Healthcare Inc, authorizing a generic lacosamide product (ANDA 218014) for us…

• FDA approval · 2024-03-27
  FDA Approved: ESLICARBAZEPINE ACETATE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin's generic eslicarbazepine acetate (original application) for use in treating partial-onset seizures in adults.

• FDA approval · 2024-03-25
  FDA Approved: LACOSAMIDE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved Dr. Reddy's Laboratories' Original Application for lacosamide (LACOSAMIDE) as a generic anticonvulsant.

• FDA approval · 2024-03-05
  FDA Approved: OXCARBAZEPINE — Original Application (Advagen Pharma Ltd.)

  FDA approved the original application for oxcarbazepine by Advagen Pharma Ltd., enabling the generic product to be marketed.

• FDA approval · 2024-02-27
  FDA Approved: ESLICARBAZEPINE ACETATE — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved eslicarbazepine acetate from Torrent Pharmaceuticals Limited under an original ANDA application.

• FDA approval · 2024-02-13
  FDA Approved: LACOSAMIDE — Original Application (Sintetica US LLC)

  FDA approves a lacosamide generic product from Sintetica US LLC under Original Application (ANDA 217311).

• FDA approval · 2024-01-26
  FDA Approved: XCOPRI — Supplemental Application (SK Life Science, Inc.)

  The FDA approved a supplemental application for XCOPRI (cenobamate) from SK Life Science, Inc., resulting in an updated labeling for the dru…

• FDA approval · 2024-01-24
  FDA Approved: LEVETIRACETAM — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for levetiracetam submitted by NorthStar RxLLC.

• FDA approval · 2024-01-24
  FDA Approved: PREGABALIN — Supplemental Application (MARKSANS PHARMA LIMITED)

  FDA approved a supplemental application for pregabalin submitted by Marksans Pharma Limited (ANDA 216197).

• FDA approval · 2024-01-24
  FDA Approved: LACOSAMIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's lacosamide Original Application (ANDA), enabling the marketing of a generic lacosamide product. Laco…

• 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 · 2023-12-13
  FDA Approved: LYRICA — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approved a supplemental application for LYRICA (pregabalin) from Pfizer's Parke-Davis division.