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: Seizures, Infantile Spasms
Sabril (vigabatrin) is an oral irreversible GABA-transaminase inhibitor for the treatment of infantile spasms and refractory complex partial seizures.
- Sabril is indicated for the treatment of:
- Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments. Sabril is not indicated as a first line agent.
- Infantile Spasms as monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.
Development timeline for Sabril
Further information
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