Partial-onset Seizures

• FDA approval · 2022-11-30
  FDA Approved: OXCARBAZEPINE — Original Application (EPIC PHARMA, LLC)

  FDA approved a generic oxcarbazepine product from Epic Pharma through an Original Application (ANDA).

• FDA approval · 2022-11-04
  FDA Approved: OXCARBAZEPINE — Original Application (Bionpharma Inc.)

  FDA approved the generic oxcarbazepine under an Original Application for Bionpharma Inc.

• FDA approval · 2022-10-03
  FDA Approved: BRIVARACETAM — Original Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a generic version of brivaracetam (BRIVARACETAM) from Zydus Pharmaceuticals USA Inc. under Original Application ANDA214501.

• FDA approval · 2022-09-30
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Vimpat (lacosamide) filed by UCB, Inc., signaling an FDA-approved expansion or modification to t…

• FDA approval · 2022-09-30
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for VIMPAT (lacosamide) submitted by UCB, Inc., resulting in a labeling update for the drug.

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• FDA approval · 2022-09-19
  FDA Approved: LACOSAMIDE — Original Application (Gland Pharma Limited)

  FDA approved an original application for lacosamide from Gland Pharma Limited to market a generic lacosamide product. The approval covers it…

• FDA approval · 2022-09-14
  FDA Approved: LACOSAMIDE — Original Application (XLCare Pharmaceuticals Inc.)

  The FDA approves XLCare Pharmaceuticals' original ANDA for lacosamide, making a generic lacosamide available in the market.

• FDA approval · 2022-09-01
  FDA Approved: PREGABALIN — Original Application (Solco Healthcare US, LLC)

  FDA approved Solco Healthcare US, LLC's original ANDA for pregabalin (generic pregabalin). This marks the approval of a generic version of p…

• FDA approval · 2022-08-26
  FDA Approved: LACOSAMIDE — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' Original Abbreviated New Drug Application for lacosamide, authorizing the marketing of a generic lacosamid…

• FDA approval · 2022-07-18
  FDA Approved: PREGABALIN — Original Application (MARKSANS PHARMA LIMITED)

  FDA approved the original ANDA for pregabalin from Marksans Pharma Limited (ANDA216197).

• FDA approval · 2022-07-15
  FDA Approved: ZONISADE — Original Application (Azurity Pharmaceuticals, Inc.)

  FDA approved ZONISADE (zonisamide) via an original NDA for use in epilepsy, including partial-onset seizures.

• FDA approval · 2022-07-15
  FDA Approved: LEVETIRACETAM — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approves Novadoz's original ANDA for Levetiracetam, establishing a generic anti-seizure medication. Indications include epilepsy-related…

• FDA approval · 2022-06-29
  FDA Approved: LACOSAMIDE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved lacosamide via an original generic application (ANDA) for Zydus Pharmaceuticals USA Inc.

• FDA approval · 2022-06-27
  FDA Approved: XCOPRI — Supplemental Application (SK Life Science, Inc.)

  The FDA approved a supplemental application for XCOPRI (cenobamate) from SK Life Science, expanding its label for seizure indications.

• FDA approval · 2022-06-09
  FDA Approved: BRIVARACETAM — Original Application (SolarisPharmaCorporation)

  FDA approved an abbreviated new drug application for brivaracetam (generic) by SolarisPharmaCorporation under ANDA214748, enabling a generic…

• FDA approval · 2022-05-31
  FDA Approved: LACOSAMIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' original application for lacosamide, enabling a generic lacosamide product to enter the market.

• FDA approval · 2022-05-19
  FDA Approved: LACOSAMIDE ORAL SOLUTION — Original Application (Ascend Laboratories, LLC)

  The FDA approved an ANDA for lacosamide oral solution from Ascend Laboratories, LLC. This generic formulation is intended for use in treatin…

• FDA approval · 2022-04-07
  FDA Approved: LACOSAMIDE — Original Application (Sagent Pharmaceuticals)

  FDA approved Sagent Pharmaceuticals' original application for lacosamide (generic), enabling marketing of a generic lacosamide product for s…

• FDA approval · 2022-03-31
  FDA Approved: LACOSAMIDE — Original Application (Ascend Laboratories, LLC)

  FDA approved lacosamide as a generic product from Ascend Laboratories under an Original Application (ANDA 214695). Lacosamide is indicated f…

• FDA approval · 2022-03-28
  FDA Approved: LEVETIRACETAM — Original Application (Solco Healthcare US, LLC)

  FDA approves Solco Healthcare US, LLC's generic levetiracetam through an Original Application (ANDA). The approval covers the same epilepsy …

• FDA approval · 2022-03-22
  FDA Approved: PREGABALIN — Original Application (Advagen Pharma Ltd.)

  FDA approved Pregabalin under an Original Application for Advagen Pharma Ltd., authorizing the generic product.

• FDA approval · 2022-03-17
  FDA Approved: LACOSAMIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical's Original Application for a generic lacosamide product, enabling its marketing as an anticonvulsant for par…

• FDA approval · 2022-03-17
  FDA Approved: LACOSAMIDE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved the original application (ANDA) for lacosamide as a generic product by Alembic Pharmaceuticals Inc., enabling its marketing as …

• FDA approval · 2022-03-17
  FDA Approved: LACOSAMIDE — Original Application (ScieGen Pharmaceuticals Inc)

  FDA approved ScieGen Pharmaceuticals Inc's lacosamide generic under an Original Application (ANDA205237) for marketing in epilepsy patients.…

• FDA approval · 2022-03-17
  FDA Approved: LACOSAMIDE — Original Application (MSN LABORATORIES PRIVATE LIMITED)

  FDA approved MSN Laboratories' original application for lacosamide as a generic anticonvulsant under an ANDA, expanding access to lacosamide…