Generalized Tonic-clonic Seizures

• FDA approval · 2014-09-25
  FDA Approved: LEVETIRACETAM — Supplemental Application (Civica, Inc.)

  FDA approved a Civica, Inc. supplemental application for Levetiracetam, approving changes to the generic product. The product is indicated f…

• FDA approval · 2014-08-07
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for KEPPRA (levetiracetam) from UCB, Inc., potentially expanding labeling or indications.

• FDA approval · 2013-08-07
  FDA Approved: LEVETIRACETAM — Supplemental Application (WG Critical Care, LLC)

  The FDA approved a supplemental application for levetiracetam submitted by WG Critical Care, LLC.

• FDA approval · 2013-07-25
  FDA Approved: KEPPRA XR — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for KEPPRA XR (levetiracetam) submitted by UCB, Inc.

• FDA approval · 2013-06-30
  FDA Approved: FYCOMPA — Supplemental Application (Eisai Inc.)

  The FDA approved Eisai's supplemental application for FYCOMPA (perampanel), resulting in changes to the product labeling.

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• FDA approval · 2013-02-27
  FDA Approved: LEVETIRACETAM — Supplemental Application (QUAGEN PHARMACEUTICALS LLC)

  FDA approved a supplemental application for levetiracetam by Quagen Pharmaceuticals LLC.

• FDA approval · 2012-04-26
  FDA Approved: LEVETIRACETAM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for Levetiracetam by Dr. Reddy's Laboratories Limited under the ANDA, reflecting an approved additio…

• FDA approval · 2012-04-26
  FDA Approved: LEVETIRACETAM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for levetiracetam by Aurobindo Pharma Limited, approving this generic product under the ANDA.

• FDA approval · 2012-04-11
  FDA Approved: LEVETIRACETAM — Original Application (QUAGEN PHARMACEUTICALS LLC)

  FDA approved the original application for levetiracetam by Quagen Pharmaceuticals LLC, making a generic version of the antiepileptic availab…

• FDA approval · 2011-10-13
  FDA Approved: LEVETIRACETAM — Original Application (Civica, Inc.)

  The FDA approved Civica, Inc.'s original application for a generic levetiracetam product. This approval provides a generic version of leveti…

• FDA approval · 2011-09-27
  FDA Approved: ZONISAMIDE — Supplemental Application (Viona Pharmaceuticals Inc)

  FDA approved a supplemental application for zonisamide submitted by Viona Pharmaceuticals, indicating approval of changes to the product.

• FDA approval · 2011-09-12
  FDA Approved: LEVETIRACETAM — Original Application (Apotex Corp.)

  FDA approves the original application for a generic levetiracetam (Apotex Corp.), enabling a generic version of the anticonvulsant for seizu…

• FDA approval · 2010-12-15
  FDA Approved: LEVETIRACETAM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for levetiracetam from Sun Pharmaceutical Industries, Inc., updating the approval status for this ge…

• FDA approval · 2010-10-08
  FDA Approved: LEVETIRACETAM — Original Application (NorthStar RxLLC)

  FDA approved a generic version of levetiracetam under an Original Application for NorthStar RxLLC.

• FDA approval · 2009-01-15
  FDA Approved: LEVETIRACETAM — Original Application (BluePoint Laboratories)

  FDA approved the original application for levetiracetam as a generic product from BluePoint Laboratories.

• FDA approval · 2009-01-15
  FDA Approved: LEVETIRACETAM — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories Limited's generic levetiracetam (Original Application), making a generic antiepileptic product availab…

• FDA approval · 2006-08-16
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Keppra (levetiracetam) submitted by UCB, Inc. The approval updates the drug's labeling per the s…