Epilepsy

• FDA approval · 2012-01-24
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for carbamazepine submitted by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2012-01-24
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for carbamazepine from Sun Pharmaceutical Industries, Inc.

• FDA approval · 2012-01-20
  FDA Approved: OXCARBAZEPINE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' supplemental application for oxcarbazepine (generic anticonvulsant) under the ANDA process.

• FDA approval · 2011-12-29
  FDA Approved: LEVETIRACETAM — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved a supplemental application for levetiracetam from Torrent Pharmaceuticals Limited under the ANDA program.

• FDA approval · 2011-12-28
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's supplemental application for oxcarbazepine, allowing the marketing of a generic version of the antiepileptic drug.

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• FDA approval · 2011-12-16
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for KEPPRA (levetiracetam) submitted by UCB, Inc., resulting in updated labeling for the drug. K…

• EMA approval · 2011-12-16
  European Medicines Agency recommends authorisation of Vimpat syrup for patients who cannot swallow tablets

  EMA recommends authorization of Vimpat syrup to treat epilepsy in patients who cannot swallow tablets, expanding the available formulation.

• FDA approval · 2011-12-16
  FDA Approved: FELBAMATE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal's felbamate original application, a generic version of felbamate.

• FDA approval · 2011-12-14
  FDA Approved: DILANTIN-125 — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2011-11-29
  FDA Approved: LAMICTAL XR — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for LAMICTAL XR (lamotrigine) from GlaxoSmithKline, indicating an updated approval related to the ex…

• FDA approval · 2011-11-25
  FDA Approved: GABAPENTIN — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for gabapentin submitted by BluePoint Laboratories.

• FDA approval · 2011-11-17
  FDA Approved: PRIMIDONE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA approved a supplemental application for Primidone from Dr. Reddy's Laboratories Limited.

• FDA approval · 2011-11-17
  FDA Approved: LEVETIRACETAM — Supplemental Application (Patrin Pharma, Inc.)

  FDA approved a supplemental application for Levetiracetam from Patrin Pharma, Inc., resulting in a supplemental approval for this generic an…

• FDA approval · 2011-11-13
  FDA Approved: CEREBYX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Cerebyx (fosphenytoin sodium) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2011-11-09
  FDA Approved: LEVETIRACETAM — Original Application (WG Critical Care, LLC)

  The FDA approved an original application for levetiracetam from WG Critical Care, LLC.

• FDA approval · 2011-11-04
  FDA Approved: TIAGABINE HYDROCHLORIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical Industries, Inc. tiagabine hydrochloride tablets as an original generic approval for adjunctive treatmen…

• FDA approval · 2011-10-30
  FDA Approved: TRILEPTAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Trileptal (oxcarbazepine) from Novartis Pharmaceuticals Corporation to update the product la…

• FDA approval · 2011-10-30
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2011-10-30
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2011-10-13
  FDA Approved: LEVETIRACETAM — Original Application (Civica, Inc.)

  The FDA approved Civica, Inc.'s original application for a generic levetiracetam product. This approval provides a generic version of leveti…

• FDA approval · 2011-10-06
  FDA Approved: LAMOTRIGINE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved Unichem Pharmaceuticals (USA), Inc.'s original application for lamotrigine, making a generic version available for treatmen…

• FDA approval · 2011-09-29
  FDA Approved: LAMOTRIGINE KIT — Supplemental Application (OWP Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for the Lamotrigine Kit from OWP Pharmaceuticals, Inc., authorizing a supplemental marketing use…

• FDA approval · 2011-09-29
  FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Lamotrigine filed by Zydus Pharmaceuticals USA Inc. The approval indicates changes under the…

• FDA approval · 2011-09-29
  FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for lamotrigine from Aurobindo Pharma Limited under ANDA090401.

• FDA approval · 2011-09-29
  FDA Approved: GABAPENTIN — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for Gabapentin submitted by BluePoint Laboratories.