Epilepsy

• FDA approval · 2013-02-28
  FDA Approved: LEVETIRACETAM — Supplemental Application (Cranbury Pharmaceuticals, LLC)

  FDA approved a supplemental application for levetiracetam submitted by Cranbury Pharmaceuticals, LLC.

• 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 · 2013-02-27
  FDA Approved: LEVETIRACETAM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for a levetiracetam generic produced by Aurobindo Pharma Limited under an ANDA.

• FDA approval · 2013-02-27
  FDA Approved: DEPAKOTE — Supplemental Application (AbbVie Inc.)

  The FDA approved AbbVie's supplemental application for DEPAKOTE (divalproex sodium), updating regulatory labeling as part of the supplementa…

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

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

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• FDA approval · 2013-02-27
  FDA Approved: LEVETIRACETAM — Supplemental Application (Patrin Pharma, Inc.)

  The FDA approved a supplemental application for levetiracetam (generic) submitted by Patrin Pharma, Inc. under ANDA078582.

• FDA approval · 2013-02-19
  FDA Approved: TOPIRAMATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for Topiramate from Unichem Pharmaceuticals (USA), Inc., confirming approval of a supplemental chang…

• FDA approval · 2013-02-08
  FDA Approved: TRILEPTAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2013-02-08
  FDA Approved: TRILEPTAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2013-02-08
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for VIMPAT (lacosamide) submitted by UCB, Inc., expanding/updating its labeling for epilepsy.

• FDA approval · 2013-02-08
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for VIMPAT (lacosamide) from UCB, Inc., resulting in a labeling update/expanded use for the anticonv…

• FDA approval · 2013-02-05
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for VIMPAT (lacosamide) submitted by UCB, Inc., marking an approved modification to the product labe…

• FDA approval · 2013-01-28
  FDA Approved: DIAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for diazepam from Teva Pharmaceuticals USA, Inc. The action represents an additional approval or mod…

• FDA approval · 2013-01-28
  FDA Approved: CLONAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for clonazepam from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2013-01-18
  FDA Approved: LAMOTRIGINE EXTENDED RELEASE — Original Application (Par Health USA, LLC)

  The FDA approved Par Health USA, LLC's Lamotrigine Extended Release as a new generic product under an original ANDA.

• 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 · 2012-12-26
  FDA Approved: LAMOTRIGINE EXTENDED-RELEASE — Original Application (Par Health USA, LLC)

  The FDA approved Par Health USA, LLC's Lamotrigine Extended-Release as an original-application generic, to be marketed for the approved epil…

• FDA approval · 2012-12-11
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved Lundbeck's supplemental application for SABRIL (vigabatrin), updating the labeling per NDA020427. This approval reflects ch…

• FDA approval · 2012-12-11
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for SABRIL (vigabatrin) from Lundbeck Pharmaceuticals LLC. The action typically updates labeling or …

• FDA approval · 2012-11-27
  FDA Approved: DILANTIN — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2012-11-27
  FDA Approved: PHENYTOIN INFATABS — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Phenytoin Infatabs from Prasco Laboratories.

• FDA approval · 2012-11-13
  FDA Approved: EQUETRO — Supplemental Application (Validus Pharmaceuticals LLC)

  The FDA approved a supplemental application for EQUETRO (carbamazepine) submitted by Validus Pharmaceuticals LLC.

• FDA approval · 2012-11-09
  FDA Approved: LEVETIRACETAM — Supplemental Application (WG Critical Care, LLC)

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

• FDA approval · 2012-10-29
  FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Topamax (topiramate) submitted by Janssen Pharmaceuticals, Inc. The approval pertains to changes…

• FDA approval · 2012-10-29
  FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Topamax (topiramate) submitted by Janssen Pharmaceuticals, Inc.