Epilepsy

• FDA approval · 2017-03-01
  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 · 2017-02-01
  FDA Approved: DILANTIN — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2017-01-25
  FDA Approved: FOSPHENYTOIN SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for fosphenytoin sodium from Hikma Pharmaceuticals USA Inc., confirming continued marketing of the g…

• FDA approval · 2017-01-09
  FDA Approved: PHENYTOIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

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

• FDA approval · 2017-01-06
  FDA Approved: TOPIRAMATE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved Heritage Pharmaceuticals' supplemental application for Topiramate Sprinkle, a generic version of topiramate. The product is man…

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• FDA approval · 2017-01-06
  FDA Approved: PHENYTOIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for phenytoin from Rising Pharma Holdings, Inc., indicating an update related to the generic antisei…

• FDA approval · 2017-01-04
  FDA Approved: LEVETIRACETAM — Original Application (Eugia US LLC)

  FDA approved a generic injectable form of levetiracetam in saline (LEVETIRACETAM IN SODIUM CHLORIDE) under an Original Application by Eugia …

• FDA approval · 2016-12-27
  FDA Approved: PHENYTEK — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for PHENYTEK (extended phenytoin sodium) from Mylan Pharmaceuticals Inc.

• FDA approval · 2016-11-30
  FDA Approved: LAMOTRIGINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

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

• FDA approval · 2016-11-08
  FDA Approved: GABAPENTIN — Supplemental Application (BluePoint Laboratories)

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

• FDA approval · 2016-11-08
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for carbamazepine submitted by Sun Pharmaceutical Industries, Inc., resulting in changes to the …

• FDA approval · 2016-11-08
  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 · 2016-11-08
  FDA Approved: GABAPENTIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals LLC's supplemental application for gabapentin (ANDA078428).

• FDA approval · 2016-11-02
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA approved a Supplemental Application for Depakote Sprinkles (divalproex sodium) submitted by AbbVie Inc.

• FDA approval · 2016-11-02
  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 for epilepsy-related …

• FDA approval · 2016-11-02
  FDA Approved: DEPAKOTE — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote (divalproex sodium) from AbbVie Inc. The action updates labeling or indications related…

• FDA approval · 2016-10-27
  FDA Approved: ACETAZOLAMIDE — Original Application (Chartwell RX, LLC)

  FDA approved an original application for acetazolamide from Chartwell RX, LLC.

• FDA approval · 2016-10-26
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for KEPPRA (levetiracetam) submitted by UCB, Inc. This action updates the drug's labeling related to…

• FDA approval · 2016-10-26
  FDA Approved: KEPPRA XR — Supplemental Application (UCB, Inc.)

  The FDA approved KEPPRA XR (extended-release levetiracetam) via a supplemental application from UCB, adding an extended-release formulation …

• FDA approval · 2016-10-26
  FDA Approved: FYCOMPA — Supplemental Application (Eisai Inc.)

  FDA approved Eisai Inc.'s supplemental application for FYCOMPA (perampanel). This action approves a supplemental indication/labeling change …

• FDA approval · 2016-09-19
  FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)

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

• FDA approval · 2016-09-16
  FDA Approved: LEVETIRACETAM — Original Application (Mylan Institutional LLC)

  FDA approved an original ANDA for levetiracetam from Mylan Institutional LLC, enabling a generic version of the anticonvulsant to reach the …

• FDA approval · 2016-09-02
  FDA Approved: LAMOTRIGINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for lamotrigine from Alembic Pharmaceuticals Limited under an ANDA. This action represents a minor r…

• FDA approval · 2016-08-09
  FDA Approved: TIAGABINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Tiagabine hydrochloride by Teva Pharmaceuticals USA, Inc. This action updates the product's …

• FDA approval · 2016-08-01
  FDA Approved: LEVETIRACETAM SOLUTION — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for LEVETIRACETAM SOLUTION (levetiracetam) from Chartwell RX, LLC, approving a new solution formulat…