Application Nr Approved Date Route Status External Links
NDA021348 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Zavesca Is A Glucosylceramide Synthase Inhibitor Indicated As Monotherapy For Treatment Of Adult Patients With Mild/moderate Type 1 Gaucher Disease For Whom Enzyme Replacement Therapy Is Not A Therapeutic Option ( 1.1 ). 1.1 Type 1 Gaucher Disease Zavesca Is A Glucosylceramide Synthase Inhibitor Indicated As Monotherapy For The Treatment Of Adult Patients With Mild To Moderate Type 1 Gaucher Disease For Whom Enzyme Replacement Therapy Is Not A Therapeutic Option (E.g. Due To Allergy, Hypersensitivity, Or Poor Venous Access).

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Miglustat MIGLUSTAT ZINC3794711

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