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Sabril FDA Approval History

FDA Approved: Yes (First approved August 21, 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 timeline 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

Further information

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