Partial-onset Seizures

• FDA approval · 2023-12-13
  FDA Approved: LYRICA CR — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for LYRICA CR (pregabalin) filed by Viatris Specialty LLC.

• 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 · 2023-11-13
  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…

• CLINICAL_TRIALS trial_result · 2023-11-09
  Clinical Trial Update: A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy [Phase 3]

  This Phase 3 trial evaluated the efficacy and safety of Brivaracetam in participants with epilepsy, including partial-onset seizures with or…

• 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 …

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• 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 · 2023-10-06
  FDA Approved: ESLICARBAZEPINE ACETATE — Original Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories, LLC's eslicarbazepine acetate as an original generic application. It is indicated as adjunctive therap…

• FDA approval · 2023-10-02
  FDA Approved: LEVETIRACETAM — Original Application (Baxter Healthcare Corporation)

  FDA approved Baxter Healthcare Corporation's original-application generic levetiracetam (ANDA 217059) for seizure disorders, establishing a …

• FDA approval · 2023-08-08
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Breckenridge Pharmaceutical, Inc.)

  FDA approved a supplemental application for oxcarbazepine by Breckenridge Pharmaceutical, Inc.

• FDA approval · 2023-08-03
  FDA Approved: ESLICARBAZEPINE ACETATE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' eslicarbazepine acetate as a generic, original-application product for adjunctive treatment of partial-…

• FDA approval · 2023-07-21
  FDA Approved: PREGABALIN — Supplemental Application (Eskayef Pharmaceuticals Limited)

  FDA approved a supplemental application for pregabalin (generic) submitted by Eskayef Pharmaceuticals Limited.

• 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.

• 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 · 2023-07-12
  FDA Approved: PREGABALIN — Original Application (Cadila Pharmaceuticals Limited)

  FDA approved Cadila Pharmaceuticals Limited's original application for pregabalin, enabling a generic version of the drug.

• FDA approval · 2023-06-26
  FDA Approved: PREGABALIN — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' supplemental application for pregabalin under ANDA 207623, indicating approval of changes to this gene…

• FDA approval · 2023-06-21
  FDA Approved: PREGABALIN — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for pregabalin from Ascend Laboratories, LLC (ANDA207799), indicating approval of a supplemental fil…

• 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 · 2023-06-09
  FDA Approved: PREGABALIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for a generic pregabalin from Rising Pharma Holdings, Inc., authorizing its marketing for the same i…

• FDA approval · 2023-06-09
  FDA Approved: PREGABALIN — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for pregabalin from Alembic Pharmaceuticals Inc., enabling a generic version to be marketed.

• FDA approval · 2023-06-09
  FDA Approved: PREGABALIN — Supplemental Application (Dr.Reddys Laboratories Inc)

  FDA approved a supplemental application for pregabalin from Dr. Reddy's Laboratories Inc., authorizing a generic version under the approved …

• FDA approval · 2023-06-09
  FDA Approved: PREGABALIN CAPSULES, CV — Supplemental Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s supplemental application for Pregabalin Capsules, CV, enabling the marketing of a generic pregabalin capsule p…

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

  The FDA approved a supplemental application for Briviact (brivaracetam) submitted by UCB, Inc., marking an approved modification to the exis…

• FDA approval · 2023-04-28
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for VIMPAT (lacosamide) submitted by UCB, Inc., finalizing the regulatory action on the product.

• FDA approval · 2023-03-31
  FDA Approved: PREGABALIN — Supplemental Application (ScieGen Pharmaceuticals, Inc)

  The FDA approved a supplemental application from ScieGen Pharmaceuticals, Inc. for a generic pregabalin product. The approval covers the sam…