Generalized Tonic-clonic Seizures

• 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.

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• CLINICAL_TRIALS trial_result · 2010-05-18
  Clinical Trial Update: Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Primary Generalized Tonic-Clonic Seizures (PGTC) Seizures [Phase 3]

  A Phase 3 study evaluating Lamictal Extended-Release as add-on therapy for primary generalized tonic-clonic seizures has completed and resul…

• 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…