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Sabril Approval History

  • FDA approved: Yes (First approved August 21st, 2009)
  • Brand name: Sabril
  • Generic name: vigabatrin
  • Dosage form: Tablets and Oral Solution
  • Company: Lundbeck Inc.
  • Treatment for: Epilepsy, Seizures

Sabril (vigabatrin) is an oral irreversible GABA-transaminase inhibitor for the treatment of Infantile Spasms and refractory complex partial seizures.

Development History and FDA Approval Process for Sabril

Aug 21, 2009Approval Lundbeck Inc. Announces FDA Marketing Approval for Sabril for the Treatment of Two Difficult-to-Treat Epilepsies
Jan  9, 2009FDA Advisory Committee Unanimously Recommends Sabril (vigabatrin) for the Treatment of Two Catastrophic Epilepsies
Feb 27, 2008FDA Accepts for Review Ovation's Two NDA Submissions for Sabril

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