Seizure Disorders

• FDA approval · 2022-05-27
  FDA Approved: LEVETIRACETAM — Original Application (ScieGen Pharmaceuticals, Inc.)

  The FDA approved an original Abbreviated New Drug Application (ANDA) for Levetiracetam from ScieGen Pharmaceuticals, establishing a generic …

• FDA approval · 2021-06-08
  FDA Approved: LEVETIRACETAM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's supplemental application for levetiracetam (generic).

• FDA approval · 2021-02-16
  FDA Approved: PHENYTOIN SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Phenytoin Sodium from Hikma Pharmaceuticals USA Inc.

• FDA approval · 2021-02-08
  FDA Approved: DIAZEPAM — Supplemental Application (Natco Pharma USA LLC)

  FDA approved a supplemental application for Diazepam from Natco Pharma USA LLC (ANDA 211998). This action confirms the continued approval/av…

• FDA approval · 2021-02-05
  FDA Approved: DIAZEPAM INTENSOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Diazepam Intensol from Hikma Pharmaceuticals USA Inc.

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• FDA approval · 2021-02-05
  FDA Approved: NAYZILAM — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Nayzilam (midazolam) by UCB, expanding its approved use/labeling. This action formalizes updated…

• FDA approval · 2021-02-05
  FDA Approved: DIAZEPAM — Supplemental Application (Meridian Medical Technologies LLC)

  The FDA approved a supplemental application for Diazepam submitted by Meridian Medical Technologies LLC.

• FDA approval · 2021-02-05
  FDA Approved: DIAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for diazepam from Hikma Pharmaceuticals USA Inc. to market a generic diazepam product.

• FDA label_change · 2021-02-05
  FDA Approved: KLONOPIN — Supplemental Application (H2-Pharma, LLC)

  The FDA approved a supplemental application for KLONOPIN (clonazepam) from H2-Pharma, LLC, resulting in changes to the product labeling.

• FDA approval · 2021-02-05
  FDA Approved: CLONAZEPAM — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for clonazepam from Alembic Pharmaceuticals Inc., bringing a generic clonazepam product to market.

• FDA approval · 2021-02-05
  FDA Approved: DIAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for Diazepam, approving a generic version of the drug.

• 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 · 2020-07-24
  FDA Approved: LEVETIRACETAM — Supplemental Application (Aryeh Pharma corp)

  FDA approved a supplemental application for levetiracetam from Aryeh Pharma Corp under ANDA 091485.

• FDA approval · 2019-04-15
  FDA Approved: CLOBAZAM — Original Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approves CLOBAZAM as an original ANDA for a generic clobazam product from Taro Pharmaceuticals U.S.A., Inc.

• FDA approval · 2019-02-21
  FDA Approved: DIAZEPAM — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Diazepam filed by Hospira, Inc. (ANDA 072079).

• FDA approval · 2019-01-30
  FDA Approved: CLOBAZAM — Original Application (Micro Labs Limited)

  The FDA approved Micro Labs Limited's generic CLOBAZAM (clobazam) under Original Application ANDA211711.

• FDA approval · 2017-12-22
  FDA Approved: PHENYTOIN INFATABS — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Phenytoin Infatabs (phenytoin) submitted by Prasco Laboratories.

• FDA approval · 2017-12-22
  FDA Approved: LORAZEPAM — Original Application (Aurolife Pharma LLC)

  FDA approved Aurolife's original application for lorazepam, a generic benzodiazepine.

• 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 · 2017-01-04
  FDA Approved: LEVETIRACETAM — Original Application (Eugia US LLC)

  FDA approved a generic injectable form of levetiracetam in saline (LEVETIRACETAM IN SODIUM CHLORIDE) under an Original Application by Eugia …

• FDA approval · 2016-12-16
  FDA Approved: CLONAZEPAM — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for clonazepam submitted by Par Health USA, LLC.

• FDA approval · 2016-12-16
  FDA Approved: CLONAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for clonazepam from Teva Pharmaceuticals USA, Inc., marking regulatory approval of an updated approv…

• FDA approval · 2016-12-16
  FDA Approved: DIAZEPAM — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application for Diazepam from Oceanside Pharmaceuticals, resulting in changes to the drug's labeling.

• CLINICAL_TRIALS trial_result · 2016-10-07
  Clinical Trial Update: A Taste and Acceptance Study of FruitiVits in Children Aged 4-8 Years Following a Ketogenic Diet. [NA]

  Clinical trial update on FruitiVits taste and acceptance in children on a ketogenic diet for seizure disorders; completed with posted result…

• FDA approval · 2016-06-16
  FDA Approved: DILANTIN-125 — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for DILANTIN-125 (phenytoin) submitted by Viatris Specialty LLC.