Epilepsy

• 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 · 2024-05-06
  FDA Approved: CLOBAZAM — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for CLOBAZAM (clobazam) submitted by Micro Labs Limited.

• FDA approval · 2024-04-25
  FDA Approved: DIAZEPAM — Original Application (Alembic Pharmaceuticals Limited)

  FDA approves Alembic Pharmaceuticals Limited's original application for a generic diazepam product. This approval supports a generic version…

• 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 · 2024-04-15
  FDA Approved: LAMOTRIGINE — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved a supplemental application for lamotrigine from Ajanta Pharma USA Inc.

• FDA approval · 2024-04-11
  FDA Approved: LAMOTRIGINE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approves Glenmark's supplemental application for lamotrigine (ANDA 079099), resulting in an approved change to the lamotrigine product u…

• FDA approval · 2024-04-08
  FDA Approved: GABAPENTIN — Original Application (Laurus Labs Limited)

  FDA approved Laurus Labs Limited's Original Application for gabapentin, permitting the marketing of a generic gabapentin product.

• FDA approval · 2024-04-05
  FDA Approved: XCOPRI — Supplemental Application (SK Life Science, Inc.)

  The FDA granted a supplemental approval for XCOPRI (cenobamate) from SK Life Science, Inc.

• 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 · 2024-03-18
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Depakote ER (divalproex sodium) submitted by AbbVie Inc.

• FDA approval · 2024-03-18
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA approved AbbVie's supplemental application for Depakote Sprinkles (divalproex sodium).

• FDA approval · 2024-03-18
  FDA Approved: OXCARBAZEPINE — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories, LLC's original ANDA for oxcarbazepine (generic), a seizure medication used to treat epilepsy.

• FDA approval · 2024-03-12
  FDA Approved: KEPPRA XR — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for KEPPRA XR (levetiracetam) from UCB, Inc., related to the extended-release formulation.

• FDA approval · 2024-03-12
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for KEPPRA (levetiracetam) from UCB, Inc. The approval updates the product labeling.

• FDA approval · 2024-03-12
  FDA Approved: LEVETIRACETAM — Supplemental Application (WG Critical Care, LLC)

  FDA approves a supplemental application for levetiracetam submitted by WG Critical Care, LLC.

• FDA approval · 2024-03-12
  FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for ONFI (clobazam) from Lundbeck Pharmaceuticals LLC.

• FDA approval · 2024-03-12
  FDA Approved: LEVETIRACETAM — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Levetiracetam filed by Prasco Laboratories.

• FDA approval · 2024-03-12
  FDA Approved: ELEPSIA XR 1000 MG — Supplemental Application (TRIPOINT THERAPEUTICS, LLC)

  FDA approved a supplemental application for ELEPSIA XR 1000 mg (levetiracetam) from Tripoint Therapeutics, LLC.

• 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 · 2024-03-01
  FDA Approved: OXCARBAZEPINE — Original Application (Biocon Pharma Inc.)

  FDA approved Biocon Pharma Inc.'s oxcarbazepine as an Original Application (ANDA) generic. The drug is indicated for the treatment of partia…

• 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 · 2024-02-27
  FDA Approved: LEVETIRACETAM — Original Application (B. Braun Medical Inc.)

  FDA approved the generic levetiracetam from B. Braun Medical Inc. under an original ANDA.