Epilepsy

• FDA approval · 2016-02-04
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for KEPPRA (levetiracetam) from UCB, Inc. The approval updates KEPPRA's labeling to reflect the supp…

• FDA approval · 2016-02-04
  FDA Approved: GABAPENTIN — Original Application (Creekwood Pharmaceuticals LLC)

  FDA approved Creekwood Pharmaceuticals LLC's gabapentin under an Abbreviated New Drug Application, authorizing the generic product's market …

• FDA approval · 2016-02-03
  FDA Approved: GABAPENTIN — Supplemental Application (Exelan Pharmaceuticals, Inc.)

  FDA approves a supplemental application for gabapentin from Exelan Pharmaceuticals, Inc., granting regulatory approval for this generic prod…

• FDA approval · 2016-02-02
  FDA Approved: LEVETIRACETAM — Supplemental Application (QUAGEN PHARMACEUTICALS LLC)

  FDA approved a supplemental application for levetiracetam from Quagen Pharmaceuticals LLC, authorizing the generic product under an ANDA and…

• FDA approval · 2016-02-01
  FDA Approved: LEVETIRACETAM — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Levetiracetam submitted by Prasco Laboratories. The update concerns changes to the product label…

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• FDA approval · 2016-02-01
  FDA Approved: LEVETIRACETAM — Original Application (Eugia US LLC)

  The FDA approved an Abbreviated New Drug Application (ANDA) for levetiracetam from Eugia US LLC, authorizing the marketing of a generic vers…

• FDA approval · 2016-01-14
  FDA Approved: LEVETIRACETAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for levetiracetam, enabling the generic version to be marketed.

• FDA approval · 2016-01-14
  FDA Approved: LEVETIRACETAM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for levetiracetam from Torrent Pharmaceuticals Limited, enabling the marketing of a generic version.

• FDA approval · 2016-01-14
  FDA Approved: LEVETIRACETAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for levetiracetam from Lupin Pharmaceuticals, Inc., related to the generic product.

• FDA approval · 2016-01-13
  FDA Approved: GABAPENTIN — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for gabapentin from Actavis Pharma, Inc., updating the approval status for this generic product.

• FDA approval · 2016-01-06
  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. The approval per…

• FDA approval · 2016-01-04
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Dr. Reddy's Laboratories Ltd)

  The FDA approved a supplemental application for divalproex sodium submitted by Dr. Reddy's Laboratories Ltd.

• FDA approval · 2015-12-26
  FDA Approved: VALPROIC ACID — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for valproic acid from Upsher-Smith Laboratories, LLC.

• FDA approval · 2015-12-23
  FDA Approved: LAMOTRIGINE — Supplemental Application (Advagen Pharma Limited)

  FDA approved a supplemental application for lamotrigine by Advagen Pharma Limited, documenting the approved generic lamotrigine product unde…

• FDA approval · 2015-12-23
  FDA Approved: OXTELLAR XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for OXTELLAR XR (oxcarbazepine) by Supernus Pharmaceuticals, Inc.

• FDA approval · 2015-12-23
  FDA Approved: GABAPENTIN — Original Application (Ascend Laboratories, LLC)

  FDA approved the gabapentin original application for Ascend Laboratories, LLC, enabling a generic version of gabapentin.

• FDA approval · 2015-12-14
  FDA Approved: LEVETIRACETAM — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Levetiracetam from Prasco Laboratories, resulting in updated labeling for this antiepileptic…

• FDA approval · 2015-12-11
  FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Lamotrigine submitted by Zydus Pharmaceuticals USA Inc., authorizing changes to the product …

• FDA approval · 2015-12-04
  FDA Approved: OXTELLAR XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)

  FDA approved a supplemental application for OXTELLAR XR (oxcarbazepine) submitted by Supernus Pharmaceuticals, indicating an approved update…

• FDA approval · 2015-11-30
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for divalproex sodium submitted by Zydus Pharmaceuticals USA Inc. The specific changes covered by th…

• FDA approval · 2015-11-30
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (BluePoint Laboratories)

  FDA approved BluePoint Laboratories' supplemental application for Divalproex Sodium under ANDA078239, granting approval of a generic product…

• FDA approval · 2015-11-12
  FDA Approved: ZONEGRAN — Supplemental Application (Advanz Pharma (US) Corp.)

  FDA approved a supplemental application for Zonegran (zonisamide) submitted by Advanz Pharma (US) Corp.

• FDA approval · 2015-11-04
  FDA Approved: TIAGABINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Tiagabine Hydrochloride from Teva Pharmaceuticals USA, Inc., updating the drug's labeling as par…

• FDA approval · 2015-11-04
  FDA Approved: FELBAMATE — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approved the original application for a generic felbamate product from ANI Pharmaceuticals, Inc.

• FDA approval · 2015-11-03
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

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