Epilepsy

• FDA approval · 2019-06-11
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for Vimpat (lacosamide) submitted by UCB, Inc.

• FDA approval · 2019-06-11
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for VIMPAT (lacosamide) submitted by UCB, Inc. The supplement likely updates the product labeling or…

• FDA approval · 2019-05-31
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for Sabril (vigabatrin) from Lundbeck Pharmaceuticals LLC. The action completes an approved suppleme…

• FDA approval · 2019-05-30
  FDA Approved: FYCOMPA — Supplemental Application (Eisai Inc.)

  The FDA approved Eisai's supplemental application for FYCOMPA (perampanel), expanding the drug's labeled uses.

• FDA approval · 2019-05-30
  FDA Approved: FYCOMPA — Supplemental Application (Eisai Inc.)

  The FDA approved Eisai's supplemental application for FYCOMPA (perampanel), marking an approval of changes to the product's labeling related…

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• FDA approval · 2019-05-30
  FDA Approved: VIGABATRIN — Supplemental Application (Par Health USA, LLC)

  FDA approved a supplemental application for Vigabatrin filed by Par Health USA, LLC.

• FDA approval · 2019-05-30
  FDA Approved: VIGABATRIN — Supplemental Application (Dr. Reddys Laboratories Inc.,)

  FDA approved a supplemental application for Vigabatrin from Dr. Reddy's Laboratories Inc., marking an approval related to a generic Vigabatr…

• FDA approval · 2019-05-17
  FDA Approved: NAYZILAM — Original Application (UCB, Inc.)

  The FDA approved Nayzilam, a nasal spray form of midazolam, under an original NDA for the acute treatment of seizures in people with epileps…

• 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: TROKENDI XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)

  FDA approved a supplemental application for TROKENDI XR (topiramate) from Supernus Pharmaceuticals, authorizing an update to the product via…

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

  The FDA approved a supplemental application for diazepam from Hospira, Inc., indicating updated labeling and continued availability under th…

• FDA approval · 2019-02-19
  FDA Approved: ETHOSUXIMIDE — Original Application (Strides Pharma Science Limited)

  FDA approves Strides Pharma Science Limited's original ANDA for ethosuximide, a generic treatment for absence seizures in epilepsy.

• 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 · 2019-01-14
  FDA Approved: VIGABATRIN — Original Application (Actavis Pharma, Inc.)

  FDA page documents Actavis Pharma's original application for a generic Vigabatrin product, seeking approval to market a generic version.

• FDA approval · 2019-01-09
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  The FDA granted approval of a supplemental application for VIMPAT (lacosamide) submitted by UCB, Inc., to update or expand its labeling.

• FDA approval · 2019-01-09
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Vimpat (lacosamide) submitted by UCB, Inc.

• FDA approval · 2019-01-09
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for VIMPAT (lacosamide) submitted by UCB, Inc. The approval represents a modification to the product…

• FDA approval · 2019-01-04
  FDA Approved: TRILEPTAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for TRILEPTAL (oxcarbazepine) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2019-01-04
  FDA Approved: TRILEPTAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Trileptal (oxcarbazepine) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2018-12-27
  FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for TOPAMAX (topiramate) from Janssen Pharmaceuticals, Inc.

• FDA approval · 2018-12-20
  FDA Approved: ELEPSIA XR 1000 MG — Original Application (TRIPOINT THERAPEUTICS, LLC)

  The FDA approved Elepsia XR 1000 mg, an extended-release formulation of levetiracetam, under an original NDA from TriPoint Therapeutics.

• FDA approval · 2018-12-13
  FDA Approved: OXTELLAR XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)

  FDA approved a supplemental NDA for OXTELLAR XR (oxcarbazepine) from Supernus Pharmaceuticals, Inc. The supplemental approval encompasses an…

• FDA approval · 2018-12-03
  FDA Approved: DILANTIN — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2018-12-03
  FDA Approved: PHENYTOIN INFATABS — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Phenytoin Infatabs, a generic phenytoin product manufactured by Prasco Laboratories.

• FDA approval · 2018-11-30
  FDA Approved: LAMOTRIGINE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's original application for a generic lamotrigine product.