Epilepsy

• FDA approval · 2014-03-07
  FDA Approved: KEPPRA XR — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application to add KEPPRA XR, an extended-release formulation of levetiracetam, to the UCB product line.

• FDA approval · 2014-02-27
  FDA Approved: DILANTIN — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2014-02-27
  FDA Approved: PHENYTOIN INFATABS — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for PHENYTOIN INFATABS (phenytoin) from Prasco Laboratories under ANDA 084427.

• FDA approval · 2014-02-19
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved Torrent Pharmaceuticals Limited's supplemental application for carbamazepine, a generic anticonvulsant.

• FDA approval · 2014-02-19
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved a supplemental application for carbamazepine from Torrent Pharmaceuticals Limited, indicating updated authorization for the…

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• FDA approval · 2014-02-19
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for divalproex sodium from Unichem Pharmaceuticals (USA), Inc., indicating an approved change or add…

• FDA approval · 2014-02-14
  FDA Approved: FYCOMPA — Supplemental Application (Eisai Inc.)

  The FDA approved Eisai Inc.'s supplemental application for FYCOMPA (perampanel).

• FDA approval · 2014-02-11
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for divalproex sodium from Zydus Pharmaceuticals USA Inc.

• FDA approval · 2014-02-05
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (NorthStar Rx LLC)

  The FDA approved a supplemental application for divalproex sodium submitted by NorthStar Rx LLC.

• FDA approval · 2014-01-27
  FDA Approved: PHENYTOIN SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for PHENYTOIN SODIUM from Hikma Pharmaceuticals USA Inc., granting the requested changes under an ap…

• FDA approval · 2014-01-24
  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 · 2014-01-18
  FDA Approved: PHENYTOIN SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Phenytoin Sodium from Sun Pharmaceutical Industries, updating its existing approval. The drug is…

• FDA approval · 2014-01-16
  FDA Approved: ZARONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for Zarontin (ethosuximide) submitted by Parke-Davis Div of Pfizer Inc, reflecting an approved m…

• FDA approval · 2014-01-16
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tegretol (carbamazepine) filed by Novartis Pharmaceuticals Corporation. The action pertains to c…

• FDA approval · 2014-01-16
  FDA Approved: PHENYTOIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for phenytoin submitted by Sun Pharmaceutical Industries, Inc., approving changes to the product.

• FDA approval · 2014-01-16
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

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

• FDA approval · 2014-01-16
  FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)

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

• FDA approval · 2014-01-16
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

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

• FDA approval · 2014-01-16
  FDA Approved: TEGRETOL XR — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2014-01-08
  FDA Approved: PHENYTEK — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for PHENYTEK, allowing an extended phenytoin sodium formulation to be marketed under the ANDA, b…

• FDA approval · 2014-01-07
  FDA Approved: ETHOSUXIMIDE — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for Ethosuximide from Bionpharma Inc. under ANDA040430.

• FDA approval · 2014-01-03
  FDA Approved: EXTENDED PHENYTOIN SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approves a supplemental application to market Extended Phenytoin Sodium (phenytoin sodium) from Amneal Pharmaceuticals LLC.

• FDA approval · 2014-01-03
  FDA Approved: CEREBYX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

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

• FDA approval · 2013-12-31
  FDA Approved: EXTENDED PHENYTOIN SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for an extended-release formulation of phenytoin sodium by Amneal Pharmaceuticals.

• FDA approval · 2013-12-26
  FDA Approved: DILANTIN — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for DILANTIN (Extended Phenytoin Sodium) submitted by Viatris Specialty LLC.