Epilepsy

• FDA approval · 2013-12-26
  FDA Approved: PHENYTOIN INFATABS — Supplemental Application (Prasco Laboratories)

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

• FDA approval · 2013-12-23
  FDA Approved: LAMOTRIGINE — Original Application (Torrent Pharmaceuticals Limited)

  FDA approves Torrent Pharmaceuticals Limited's generic lamotrigine through an Original Application (ANDA). Lamotrigine is used to treat epil…

• FDA approval · 2013-12-20
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for LAMICTAL (lamotrigine) filed by GlaxoSmithKline LLC.

• FDA approval · 2013-12-20
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal ODT (lamotrigine) from GlaxoSmithKline LLC.

• FDA approval · 2013-12-20
  FDA Approved: LAMICTAL XR — Supplemental Application (GlaxoSmithKline LLC)

  FDA approves a supplemental application for Lamictal XR (lamotrigine) submitted by GlaxoSmithKline LLC.

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• FDA approval · 2013-11-21
  FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved a supplemental application for ONFI (clobazam) filed by Lundbeck Pharmaceuticals LLC.

• FDA approval · 2013-11-08
  FDA Approved: APTIOM — Original Application (Sumitomo Pharma America, Inc.)

  FDA approved APTIOM (eslicarbazepine acetate) from Sumitomo Pharma America as an original NDA for use in adults with partial-onset seizures …

• FDA approval · 2013-11-08
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tegretol (carbamazepine) submitted by Novartis Pharmaceuticals Corporation. The approval updates…

• FDA approval · 2013-11-08
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approves a supplemental application for Tegretol (carbamazepine) submitted by Novartis Pharmaceuticals Corporation, resulting in an upda…

• FDA approval · 2013-10-17
  FDA Approved: LAMOTRIGINE — Original Application (Actavis Pharma, Inc.)

  FDA approved a generic lamotrigine product from Actavis Pharma under an Original Application (ANDA 200672).

• FDA approval · 2013-10-11
  FDA Approved: ZONEGRAN — Supplemental Application (Advanz Pharma (US) Corp.)

  The FDA approved a supplemental application for Zonegran (zonisamide) submitted by Advanz Pharma (US) Corp., updating the labeling for Zoneg…

• FDA approval · 2013-10-11
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  FDA has approved a supplemental application for Vimpat (lacosamide) submitted by UCB, Inc., updating the product labeling. This approval upd…

• FDA approval · 2013-10-04
  FDA Approved: LEVETIRACETAM — Supplemental Application (WG Critical Care, LLC)

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

• FDA approval · 2013-10-02
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for Vimpat (lacosamide) filed by UCB, Inc., resulting in an approved modification to the product…

• FDA approval · 2013-09-25
  FDA Approved: FOSPHENYTOIN SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for fosphenytoin sodium by Hikma Pharmaceuticals USA Inc., approving changes to the approved product…

• FDA approval · 2013-09-25
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for VIMPAT (lacosamide) submitted by UCB, Inc. to update its labeling.

• FDA approval · 2013-09-25
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for VIMPAT (lacosamide) from UCB, Inc. This supplemental approval updates the existing NDA, typi…

• FDA approval · 2013-09-25
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for VIMPAT (lacosamide) from UCB, Inc., resulting in an update to its labeling.

• FDA approval · 2013-09-13
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for KEPPRA (levetiracetam) submitted by UCB, Inc., under NDA021505, to update the product labeli…

• FDA approval · 2013-09-06
  FDA Approved: DILANTIN-125 — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2013-08-23
  FDA Approved: OXTELLAR XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)

  FDA approved a supplemental application for OXTELLAR XR (oxcarbazepine) from Supernus Pharmaceuticals, updating the product labeling.

• FDA approval · 2013-08-22
  FDA Approved: FOSPHENYTOIN — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Fosphenytoin Sodium (Fosphenytoin) by Fresenius Kabi USA, LLC.

• FDA approval · 2013-08-16
  FDA Approved: TROKENDI XR — Original Application (Supernus Pharmaceuticals, Inc.)

  FDA approved TROKENDI XR (topiramate extended-release) in an Original Application by Supernus Pharmaceuticals, expanding the topiramate port…

• FDA approval · 2013-08-08
  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 · 2013-08-07
  FDA Approved: LEVETIRACETAM — Supplemental Application (WG Critical Care, LLC)

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