miglustat
Drug Details
- Generic Name
- miglustat
- Brand Names
- Zavesca, Miglustat, OPFOLDA
- Application Number
- NDA021348
- Sponsor
- Actelion Pharmaceuticals US, Inc.
- NDC Codes
- 3
- Dosage Forms
- CAPSULE
- Routes
- ORAL
- Active Ingredients
- MIGLUSTAT
Indications and Usage
1 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 ). 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).