Juvenile Myoclonic Epilepsy

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

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

• FDA approval · 2012-04-11
  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 · 2011-12-29
  FDA Approved: LEVETIRACETAM — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved a supplemental application for levetiracetam from Torrent Pharmaceuticals Limited under the ANDA program.

• FDA approval · 2011-12-16
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for KEPPRA (levetiracetam) submitted by UCB, Inc., resulting in updated labeling for the drug. K…

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• 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…

• CLINICAL_TRIALS research · 2011-10-12
  Clinical Trial Update: Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy [Phase 2]

  This clinical trial update describes a Phase 2 study investigating the effects of physical exercise in individuals with juvenile myoclonic e…

• FDA approval · 2011-09-12
  FDA Approved: LEVETIRACETAM — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' generic version of levetiracetam through an Original Application (ANDA), adding a generic option for thi…

• 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 · 2010-12-14
  FDA Approved: LEVETIRACETAM — Original Application (Cranbury Pharmaceuticals, LLC)

  FDA approves Cranbury Pharmaceuticals' original application for a generic levetiracetam, supporting its use for partial-onset seizures, myoc…

• FDA approval · 2010-12-13
  FDA Approved: LEVETIRACETAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for levetiracetam from Aurobindo Pharma Limited, authorizing a generic Levetiracetam product under a…

• FDA approval · 2009-12-08
  FDA Approved: LEVETIRACETAM — Original Application (Mylan Pharmaceuticals Inc.)

  The FDA approved Mylan Pharmaceuticals' original application for a generic levetiracetam product (LEVETIRACETAM) for use in treating seizure…

• FDA approval · 2009-08-24
  FDA Approved: LEVETIRACETAM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for LEVETIRACETAM by Sun Pharmaceutical Industries, Inc., updating labeling based on the submission.…

• FDA approval · 2009-08-20
  FDA Approved: LEVETIRACETAM SOLUTION — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application to add a levetiracetam solution dosage form (generic) under Chartwell RX, LLC.

• 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 · 2009-01-15
  FDA Approved: LEVETIRACETAM — Original Application (Aurobindo Pharma Limited)

  The FDA approved a generic levetiracetam product from Aurobindo Pharma Limited under an Original Application (ANDA 079063). This clearance a…

• 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…