Epilepsy

• FDA approval · 2017-08-14
  FDA Approved: LEVETIRACETAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application to authorize Aurobindo Pharma Limited to manufacture levetiracetam (generic) in the United States.

• FDA approval · 2017-07-26
  FDA Approved: FYCOMPA — Supplemental Application (Eisai Inc.)

  FDA approved Eisai Inc.'s supplemental application for FYCOMPA (perampanel), updating the labeling to reflect the approved change.

• FDA approval · 2017-07-26
  FDA Approved: FYCOMPA — Supplemental Application (Eisai Inc.)

  FDA approved a supplemental application for FYCOMPA (perampanel) submitted by Eisai Inc. The action expands the product's labeling to reflec…

• FDA approval · 2017-06-16
  FDA Approved: FELBAMATE — Original Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approved the original application for Felbamate, authorizing its generic marketing in the United States by Taro Pharmaceuticals U.S.A., …

• FDA approval · 2017-06-16
  FDA Approved: LAMOTRIGINE KIT — Supplemental Application (OWP Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Lamotrigine Kit from OWP Pharmaceuticals, Inc., enabling its marketing as a lamotrigine-based pr…

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• FDA approval · 2017-06-09
  FDA Approved: LEVETIRACETAM — Supplemental Application (Prasco Laboratories)

  FDA approves a supplemental application for levetiracetam by Prasco Laboratories, enabling a generic version to be marketed.

• FDA approval · 2017-06-08
  FDA Approved: GABAPENTIN — Supplemental Application (Acella Pharmaceuticals, LLC)

  FDA approved a supplemental application for gabapentin from Acella Pharmaceuticals, LLC.

• FDA approval · 2017-05-30
  FDA Approved: FELBAMATE — Original Application (Zydus Lifesciences Limited)

  FDA approved Felbamate from Zydus Lifesciences Limited under an Original Application (ANDA).

• CLINICAL_TRIALS approval · 2017-05-09
  Clinical Trial Update: Long Term Study of the Safety of OXC XR as in Pediatric Epilepsy Subjects

  OXC XR has been approved for marketing for pediatric epilepsy based on a long-term safety study.

• FDA approval · 2017-05-05
  FDA Approved: ETHOSUXIMIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for Ethosuximide (PAI Pharma) to update the product labeling.

• FDA approval · 2017-04-27
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for Sabril (vigabatrin) from Lundbeck Pharmaceuticals LLC.

• FDA approval · 2017-04-27
  FDA Approved: VIGABATRIN — Original Application (Par Health USA, LLC)

  FDA approves Vigabatrin original Abbreviated New Drug Application for Par Health USA, LLC (generic entry).

• FDA approval · 2017-04-25
  FDA Approved: LAMOTRIGINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved a supplemental application for Lamotrigine from Torrent Pharmaceuticals Limited (ANDA203370). The action updates the produc…

• FDA approval · 2017-04-24
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for KEPPRA (levetiracetam) from UCB, Inc., expanding or updating its labeling for the drug.

• FDA approval · 2017-04-24
  FDA Approved: KEPPRA XR — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for KEPPRA XR (levetiracetam), authorizing the extended-release formulation from UCB, for use in epi…

• FDA approval · 2017-04-24
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for KEPPRA (levetiracetam) by UCB, Inc., authorizing changes to its labeling and/or indications.

• FDA approval · 2017-04-20
  FDA Approved: FELBAMATE — Original Application (Taro Pharmaceuticals U.S.A., inc.)

  FDA approves the original ANDA application for Felbamate from Taro Pharmaceuticals U.S.A., enabling a generic version of the antiepileptic d…

• FDA approval · 2017-04-18
  FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Lamotrigine by Aurobindo Pharma Limited, enabling a new generic version of lamotrigine.

• FDA approval · 2017-03-29
  FDA Approved: TOPIRAMATE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for Topiramate submitted by Upsher-Smith Laboratories, LLC.

• FDA approval · 2017-03-24
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for Vimpat (lacosamide) submitted by UCB, Inc., updating the product’s label to reflect the requ…

• FDA approval · 2017-03-24
  FDA Approved: NEURONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA supplemental approval for Neurontin (gabapentin) by Parke-Davis Division of Pfizer Inc.

• FDA approval · 2017-03-24
  FDA Approved: GABAPENTIN — Original Application (Rising Pharma Holdings, Inc.)

  FDA approves Rising Pharma's original application for gabapentin, a generic version of the anticonvulsant, for the treatment of epilepsy (pa…

• FDA approval · 2017-03-10
  FDA Approved: CEREBYX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Cerebyx (fosphenytoin sodium) from Pfizer Laboratories Div Pfizer Inc. The approval updates …

• FDA approval · 2017-03-07
  FDA Approved: APTIOM — Supplemental Application (Sumitomo Pharma America, Inc.)

  The FDA approved a supplemental application for APTIOM (eslicarbazepine acetate) submitted by Sumitomo Pharma America, Inc.

• FDA approval · 2017-03-06
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA approves a supplemental application for Depakote Sprinkles (divalproex sodium) from AbbVie, authorizing changes to the product labeling …