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Treats mild/moderate type 1 Gaucher disease. NDA 21348, held by Actelion. Miglustat.
As of Nov 14, 2026, NDA 21348 (Zavesca), held by Actelion, was first approved by FDA on Jul 31, 2003, with 7 approved supplements and 0 published complete response letters.
First approved: Jul 31, 2003
Review: Standard
Supplements approved: 7
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Miglustat 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 Type 1 Gaucher Disease Miglustat is 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).
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
