Generalized Tonic-clonic Seizures

• FDA approval · 2025-07-11
  FDA Approved: PERAMPANEL — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved the original ANDA for PERAMPANEL from Novadoz Pharmaceuticals LLC, making a generic version of perampanel available. This suppo…

• FDA approval · 2025-05-23
  FDA Approved: PERAMPANEL — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva Pharmaceuticals' original application for a generic version of perampanel. The product is manufactured by Teva Pharmaceuti…

• FDA approval · 2025-02-25
  FDA Approved: LEVETIRACETAM — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for an oral generic formulation of levetiracetam. This approval enables Camber…

• FDA approval · 2025-02-05
  FDA Approved: LEVETIRACETAM — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application from BluePoint Laboratories for levetiracetam, authorizing approval of a generic version of the anti…

• 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…

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• FDA approval · 2024-07-05
  FDA Approved: LEVETIRACETAM — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for Levetiracetam from Micro Labs Limited.

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

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

• 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 · 2023-06-13
  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 · 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 · 2022-03-28
  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 · 2021-06-11
  FDA Approved: LEVETIRACETAM — Original Application (ScieGen Pharmaceuticals, Inc.)

  FDA approved the original application (ANDA) for LEVETIRACETAM by ScieGen Pharmaceuticals, authorizing the generic product.

• FDA approval · 2021-01-19
  FDA Approved: LEVETIRACETAM — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for LEVETIRACETAM filed by Prasco Laboratories.

• FDA approval · 2020-09-30
  FDA Approved: KEPPRA XR — Supplemental Application (UCB, Inc.)

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

• FDA approval · 2020-06-11
  FDA Approved: LEVETIRACETAM EXTENDED-RELEASE — Original Application (Omnivium Pharmaceuticals LLC)

  FDA approved an extended-release generic formulation of levetiracetam (ANDA212688) manufactured by Omnivium Pharmaceuticals LLC.

• FDA approval · 2018-03-08
  FDA Approved: FOSPHENYTOIN SODIUM — Supplemental Application (West-Ward Pharmaceuticals Corp)

  FDA approved a supplemental application for fosphenytoin sodium submitted by West-Ward Pharmaceuticals Corp. The action updates labeling for…

• FDA approval · 2017-08-14
  FDA Approved: LEVETIRACETAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application to authorize Aurobindo Pharma Limited to manufacture levetiracetam (generic) in the United States.

• FDA approval · 2017-06-09
  FDA Approved: LEVETIRACETAM — Supplemental Application (Prasco Laboratories)

  FDA approves a supplemental application for levetiracetam by Prasco Laboratories, enabling a generic version to be marketed.

• FDA approval · 2016-09-16
  FDA Approved: LEVETIRACETAM — Original Application (Mylan Institutional LLC)

  FDA approved an original ANDA for levetiracetam from Mylan Institutional LLC, enabling a generic version of the anticonvulsant to reach the …

• FDA approval · 2015-12-14
  FDA Approved: LEVETIRACETAM — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Levetiracetam from Prasco Laboratories, resulting in updated labeling for this antiepileptic…

• FDA approval · 2015-10-02
  FDA Approved: LEVETIRACETAM — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals LLC's supplemental application for levetiracetam, a generic form of the antiepileptic drug, under up…

• FDA approval · 2015-08-13
  FDA Approved: LEVETIRACETAM — Original Application (Fresenius Kabi USA, LLC)

  The FDA approved Fresenius Kabi USA, LLC's generic levetiracetam, expanding access to an anticonvulsant used to treat various seizure disord…

• FDA approval · 2015-06-19
  FDA Approved: FYCOMPA — Supplemental Application (Eisai Inc.)

  The FDA approved a supplemental application for FYCOMPA (perampanel) from Eisai Inc., resulting in an updated labeling for the drug.

• FDA approval · 2015-06-04
  FDA Approved: LEVETIRACETAM — Original Application (Major Pharmaceuticals)

  FDA approved the Original Application for levetiracetam from Major Pharmaceuticals, making a generic version of the anticonvulsant available…