Juvenile Myoclonic Epilepsy

• EMA approval · 2025-10-20
  EMA Authorised: Diacomit (stiripentol) — Biocodex

  The EMA authorised Diacomit (stiripentol) in the EU for juvenile myoclonic epilepsy, with Biocodex as the marketing authorization holder. Th…

• 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 · 2025-02-14
  FDA Approved: LEVETIRACETAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for levetiracetam, updating the product's labeling/indications.

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

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

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

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

• 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 · 2020-11-27
  FDA Approved: LEVETIRACETAM ER — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals' generic extended-release levetiracetam tablet (LEVETIRACETAM ER) under an Original Abbreviated New…

• 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 · 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 · 2016-08-01
  FDA Approved: LEVETIRACETAM SOLUTION — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for LEVETIRACETAM SOLUTION (levetiracetam) from Chartwell RX, LLC, approving a new solution formulat…

• FDA approval · 2016-02-01
  FDA Approved: LEVETIRACETAM — Original Application (Eugia US LLC)

  The FDA approved an Abbreviated New Drug Application (ANDA) for levetiracetam from Eugia US LLC, authorizing the marketing of a generic vers…

• 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 · 2015-06-04
  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…

• FDA approval · 2015-03-10
  FDA Approved: KEPPRA XR — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for KEPPRA XR (levetiracetam) from UCB, authorizing an extended-release formulation for use in epile…

• FDA approval · 2014-09-25
  FDA Approved: LEVETIRACETAM — Supplemental Application (Civica, Inc.)

  FDA approved a Civica, Inc. supplemental application for Levetiracetam, approving changes to the generic product. The product is indicated f…

• FDA approval · 2014-08-07
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for KEPPRA (levetiracetam) from UCB, Inc., potentially expanding labeling or indications.

• FDA approval · 2013-08-07
  FDA Approved: LEVETIRACETAM — Supplemental Application (WG Critical Care, LLC)

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

• FDA approval · 2013-02-27
  FDA Approved: LEVETIRACETAM — Supplemental Application (QUAGEN PHARMACEUTICALS LLC)

  FDA approved a supplemental application for levetiracetam by Quagen Pharmaceuticals LLC.