Epilepsy

• FDA approval · 2015-10-30
  FDA Approved: FLUDEOXYGLUCOSE F18 — Original Application (3D Imaging Drug Design and Development LLC)

  FDA approved Fluorodeoxyglucose F18 (FDG F-18) as an original radiopharmaceutical for PET imaging to assess metabolic activity in oncology, …

• FDA approval · 2015-10-30
  FDA Approved: TOPIRAMATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' supplemental application for Topiramate, updating the approved labeling for the product.

• FDA approval · 2015-10-30
  FDA Approved: TOPIRAMATE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Topiramate submitted by Zydus Lifesciences Limited.

• FDA approval · 2015-10-27
  FDA Approved: LAMOTRIGINE — Original Application (Endo USA, Inc.)

  FDA approved Endo USA, Inc.'s generic lamotrigine under ANDA204158, allowing the generic product to be marketed for the same indications as …

• FDA approval · 2015-10-26
  FDA Approved: ZONISAMIDE — Supplemental Application (BluePoint Laboratories)

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

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• FDA approval · 2015-10-19
  FDA Approved: LEVETIRACETAM — Supplemental Application (Prinston Pharmaceutical Inc.)

  FDA approved a supplemental application for levetiracetam from Prinston Pharmaceutical Inc. under ANDA078106.

• FDA approval · 2015-10-15
  FDA Approved: FOSPHENYTOIN SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Fosphenytoin Sodium from Amneal Pharmaceuticals LLC, adding an updated approval for this generic…

• FDA approval · 2015-10-12
  FDA Approved: TROKENDI XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)

  FDA approved a supplemental application for TROKENDI XR (topiramate) filed by Supernus Pharmaceuticals, Inc., indicating an expanded or upda…

• FDA approval · 2015-10-02
  FDA Approved: LEVETIRACETAM — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals LLC's supplemental application for levetiracetam, a generic form of the antiepileptic drug, under up…

• FDA approval · 2015-10-01
  FDA Tentative Approval: LAMOTRIGINE — Supplemental Application (NorthStar Rx LLC)

  FDA tentatively approved NorthStar Rx LLC's generic lamotrigine product under an ANDA.

• FDA approval · 2015-09-23
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote Sprinkles (divalproex sodium) from AbbVie, adding the sprinkle formulation to the produ…

• FDA approval · 2015-09-23
  FDA Approved: DEPAKOTE — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote (divalproex sodium) submitted by AbbVie Inc.

• FDA approval · 2015-09-23
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for divalproex sodium from Aurobindo Pharma Limited.

• FDA approval · 2015-09-17
  FDA Approved: GABAPENTIN — Supplemental Application (Advagen Pharma Ltd)

  FDA approved a supplemental application for gabapentin filed by Advagen Pharma Ltd. The approval updates the approved generic product as par…

• FDA approval · 2015-09-17
  FDA Approved: GABAPENTIN — Supplemental Application (Granules Pharmaceuticals Inc)

  The FDA approved a supplemental application for Gabapentin from Granules Pharmaceuticals Inc, authorizing a generic gabapentin product to be…

• FDA approval · 2015-09-11
  FDA Approved: OXTELLAR XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)

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

• FDA approval · 2015-09-10
  FDA Approved: GABAPENTIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for gabapentin filed by Sun Pharmaceutical Industries, Inc. The approval reflects a supplemental cha…

• FDA approval · 2015-09-10
  FDA Approved: APTIOM — Supplemental Application (Sumitomo Pharma America, Inc.)

  FDA approved a supplemental application for APTIOM (eslicarbazepine acetate) from Sumitomo Pharma America, Inc., signaling an update to the …

• FDA approval · 2015-08-14
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for KEPPRA (levetiracetam) from UCB, Inc., resulting in an approved change to the drug's labeling.

• FDA approval · 2015-08-13
  FDA Approved: LEVETIRACETAM — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved a supplemental application for Levetiracetam from Torrent Pharmaceuticals Limited, updating the approved labeling under an …

• FDA approval · 2015-08-13
  FDA Approved: LEVETIRACETAM — Original Application (Fresenius Kabi USA, LLC)

  The FDA approved Fresenius Kabi USA, LLC's generic levetiracetam, expanding access to an anticonvulsant used to treat various seizure disord…

• FDA approval · 2015-08-10
  FDA Approved: LEVETIRACETAM — Supplemental Application (Cranbury Pharmaceuticals, LLC)

  FDA approved a supplemental application for levetiracetam (generic) submitted by Cranbury Pharmaceuticals, LLC. The action reflects an updat…

• FDA approval · 2015-08-10
  FDA Approved: LEVETIRACETAM — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for levetiracetam from Amneal Pharmaceuticals LLC, advancing a generic version of the antiseizur…

• FDA approval · 2015-07-31
  FDA Approved: LEVETIRACETAM — Original Application (Prasco Laboratories)

  FDA approved an original application for levetiracetam by Prasco Laboratories.

• FDA approval · 2015-07-09
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  The FDA approved a Supplemental Application for VIMPAT (lacosamide) filed by UCB, Inc.