Partial-onset Seizures

• 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 …

• 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.

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• 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.

• 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…

• 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 …

• 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.