Seizure Disorders

• 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 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.

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• 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.

• 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.

• FDA approval · 2016-05-02
  FDA Approved: DIAZEPAM INTENSOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Diazepam Intensol from Hikma Pharmaceuticals USA Inc., confirming changes to the approved pr…

• FDA approval · 2016-04-18
  FDA Approved: LORAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Lorazepam from Hikma Pharmaceuticals USA Inc., indicating an approved update to the drug's l…

• FDA approval · 2016-03-24
  FDA Approved: DIAZEPAM — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application to Chartwell RX, LLC for diazepam oral solution (concentrate), authorizing a generic version of this…

• FDA approval · 2015-05-18
  FDA Approved: CLONAZEPAM — Supplemental Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare Inc.'s Supplemental Application for clonazepam, making a supplemental approval under the approved ANDA. Clona…

• FDA approval · 2015-04-16
  FDA Approved: DILANTIN — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for DILANTIN (extended phenytoin sodium), a new extended-release form from Viatris Specialty LLC.

• 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 · 2014-04-14
  FDA Approved: DIAZEPAM — Original Application (Chartwell RX, LLC)

  FDA approved Chartwell RX, LLC's original application for diazepam oral solution (concentrate) as a generic product.