Seizures

• FDA approval · 2025-04-04
  FDA Approved: LEVETIRACETAM — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Levetiracetam (generic) submitted by Fresenius Kabi USA, LLC, under ANDA090876.

• FDA approval · 2025-03-10
  FDA Approved: LEVETIRACETAM — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental application for Levetiracetam in Sodium Chloride from Eugia US LLC, adding a salt-form formulation of levetirace…

• FDA approval · 2024-05-24
  FDA Approved: CLOBAZAM — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for CLOBAZAM filed by Bionpharma Inc., confirming an additional approval for this clobazam produ…

• FDA approval · 2024-02-12
  FDA Approved: LEVETIRACETAM IN SODIUM CHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s generic levetiracetam in sodium chloride injection under an Original Application.

• FDA approval · 2023-01-13
  FDA Approved: NAYZILAM — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Nayzilam (midazolam) from UCB, Inc.

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• FDA approval · 2022-08-24
  FDA Approved: FOSPHENYTOIN SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for fosphenytoin sodium submitted by Amneal Pharmaceuticals LLC.

• FDA approval · 2021-06-23
  FDA Approved: DIAZEPAM — Supplemental Application (Natco Pharma USA LLC)

  FDA approved Natco Pharma USA LLC's supplemental application for Diazepam (generic).

• FDA approval · 2020-08-28
  FDA Approved: FOSPHENYTOIN — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for fosphenytoin sodium (Fosphenytoin) from Fresenius Kabi USA, LLC. The action confirms an approved…

• FDA approval · 2020-01-28
  FDA Approved: CEREBYX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for CEREBYX (fosphenytoin sodium) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2019-10-21
  FDA Approved: FOSPHENYTOIN SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for fosphenytoin sodium from Amneal Pharmaceuticals LLC.

• FDA approval · 2016-06-16
  FDA Approved: CEREBYX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Cerebyx (fosphenytoin sodium) submitted by Pfizer Laboratories Div Pfizer Inc, expanding the…

• FDA approval · 2016-05-16
  FDA Approved: FOSPHENYTOIN — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for fosphenytoin sodium from Fresenius Kabi USA, LLC under an existing ANDA.

• FDA approval · 2013-02-28
  FDA Approved: LEVETIRACETAM — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original ANDA for levetiracetam oral, authorizing a generic version of the antiepileptic drug.

• FDA approval · 2012-12-26
  FDA Approved: PHENYTOIN — Original Application (Rising Pharma Holdings, Inc.)

  FDA approves Rising Pharma's original ANDA for phenytoin, permitting a generic version of this antiseizure drug for seizure disorders.

• FDA approval · 2011-11-13
  FDA Approved: CEREBYX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Cerebyx (fosphenytoin sodium) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2009-12-02
  FDA Approved: FOSPHENYTOIN SODIUM — Original Application (West-Ward Pharmaceuticals Corp)

  FDA approved the original application for fosphenytoin sodium (generic) from West-Ward Pharmaceuticals Corp, authorizing its use as an antic…

• FDA approval · 2008-03-18
  FDA Approved: FOSPHENYTOIN SODIUM — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's original application for fosphenytoin sodium (ANDA 078476), establishing a generic option for seiz…

• FDA approval · 2007-08-08
  FDA Approved: DILANTIN — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Dilantin (extended phenytoin sodium) filed by Viatris Specialty LLC.