Application Nr Approved Date Route Status External Links
ANDA204521 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & Usage Pimozide Tablets, Usp Is Indicated For The Suppression Of Motor And Phonic Tics In Patients With Tourette’s Disorder Who Have Failed To Respond Satisfactorily To Standard Treatment. Pimozide Tablets, Usp Is Not Intended As A Treatment Of First Choice Nor Is It Intended For The Treatment Of Tics That Are Merely Annoying Or Cosmetically Troublesome. Pimozide Tablets, Usp Should Be Reserved For Use In Tourette’s Disorder Patients Whose Development And/or Daily Life Function Is Severely Compromised By The Presence Of Motor And Phonic Tics. Evidence Supporting Approval Of Pimozide Tablets, Usp For Use In Tourette’s Disorder Was Obtained In Two Controlled Clinical Investigations Which Enrolled Patients Between The Ages Of 8 And 53 Years. Most Subjects In The Two Trials Were 12 Or Older.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Pimozide PIMOZIDE ZINC4175630

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