Partial-onset Seizures

• 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 · 2011-08-10
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

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

• FDA approval · 2011-08-10
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for VIMPAT (lacosamide) from UCB, Inc., updating the labeling and/or indications for this antiep…

• FDA approval · 2011-06-20
  FDA Approved: LYRICA — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approved a supplemental application for LYRICA (pregabalin) submitted by Parke-Davis Div of Pfizer Inc.

• FDA approval · 2011-04-26
  FDA Approved: PREGABALIN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for pregabalin submitted by Mylan Pharmaceuticals Inc., updating the regulatory status of the produc…

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• 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 · 2010-10-22
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Advagen Pharma Limited)

  FDA approved a supplemental application for oxcarbazepine submitted by Advagen Pharma Limited.

• 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 · 2010-06-29
  FDA Approved: OXCARBAZEPINE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for oxcarbazepine by ANI Pharmaceuticals, Inc., updating regulatory approvals for this product.

• FDA approval · 2010-05-31
  FDA Approved: ZONISAMIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical's supplemental application for Zonisamide (zonisamide), indicating an update to the approved product.

• FDA approval · 2010-04-20
  FDA Approved: VIMPAT — Original Application (UCB, Inc.)

  FDA approved VIMPAT (lacosamide) through its Original Application submitted by UCB, Inc.

• FDA approval · 2010-02-26
  FDA Approved: ZONISAMIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for zonisamide submitted by Aurobindo Pharma Limited. The approval confirms the changes requeste…

• FDA approval · 2010-01-04
  FDA Approved: PREGABALIN — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved the original application for pregabalin from Mylan Pharmaceuticals, confirming a generic version of the drug.

• FDA approval · 2009-11-18
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for Vimpat (lacosamide) to expand its approved indications.

• 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 · 2008-10-28
  FDA Approved: VIMPAT — Original Application (UCB, Inc.)

  FDA approved VIMPAT (lacosamide) under Original Application by UCB, Inc., marking the initial approval for the treatment of partial-onset se…

• FDA approval · 2008-10-28
  FDA Approved: VIMPAT — Original Application (UCB, Inc.)

  FDA approved VIMPAT (lacosamide) through its original NDA for adjunctive treatment of partial-onset seizures in adults and in pediatric pati…

• FDA approval · 2007-12-11
  FDA Approved: OXCARBAZEPINE — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' original application for oxcarbazepine, a generic anticonvulsant indicated for partial-onset seizures …

• FDA approval · 2007-10-09
  FDA Approved: OXCARBAZEPINE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved the original ANDA for oxcarbazepine from Glenmark Pharmaceuticals.

• FDA approval · 2007-09-12
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Keppra (levetiracetam) from UCB, Inc., expanding the product's approved use and/or labeling.

• FDA approval · 2007-07-25
  FDA Approved: GABAPENTIN — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals LLC's original ANDA for gabapentin, providing a generic version of the anti-epileptic medication. Th…