Application Nr Approved Date Route Status External Links
NDA022006 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage 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 ( 1.1 ) Infantile Spasms - Monotherapy In Infants 1 Month To 2 Years Of Age For Whom The Potential Benefits Outweigh The Potential Risk Of Vision Loss ( 1.2 ) 1.1 Refractory Complex Partial Seizures (Cps) Sabril Is Indicated As Adjunctive Therapy For Adults And Pediatric Patients 2 Years Of Age And Older With Refractory Complex Partial Seizures Who Have Inadequately Responded To Several Alternative Treatments And For Whom The Potential Benefits Outweigh The Risk Of Vision Loss [See Warnings And Precautions ( 5.1 )] . Sabril Is Not Indicated As A First Line Agent For Complex Partial Seizures. 1.2 Infantile Spasms (Is) Sabril Is Indicated As Monotherapy For Pediatric Patients With Infantile Spasms 1 Month To 2 Years Of Age For Whom The Potential Benefits Outweigh The Potential Risk Of Vision Loss [See Warnings And Precautions ( 5.1 ) ].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Vigabatrin VIGABATRIN ZINC403618

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