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Details for Generic Name: miglustat

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Miglustat is the generic ingredient in one branded drug marketed by Actelion Pharms Ltd and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for miglustat. One supplier is listed for this compound.

Summary for Generic Name: miglustat

Drug Master File Entries: see list2
Suppliers / Packaging: see list1
Therapeutic Class:Enzyme Replacements/Modifiers
Formulation / Manufacturing:see details

Pharmacology for Ingredient: miglustat

Clinical Trials for: miglustat

Effect of Miglustat on the Nasal Potential Difference in Patients With Cystic Fibrosis Homozygous for the F508del Mutation
Status: Recruiting Condition: Cystic Fibrosis

Application of Miglustat in Patients With Niemann-Pick Type C
Status: Completed Condition: Niemann-Pick Disease Type C

Miglustat on Gaucher Disease Type IIIB
Status: Recruiting Condition: Gaucher Disease

Miglustat in Niemann-Pick Type C Disease
Status: Completed Condition: Niemann-Pick Type C Disease

Miglustat / OGT 918 in the Treatment of Cystic Fibrosis
Status: Terminated Condition: Cystic Fibrosis

Does a Nasal Instillation of Miglustat Normalize the Nasal Potential Difference in Cystic Fibrosis Patients ?
Status: Completed Condition: Cystic Fibrosis

Oral Miglustat in Adult Patients With Stable Type 1 Gaucher Disease
Status: Completed Condition: Type 1 Gaucher Disease

A Pilot Study of Zavesca® in Patients With Pompe Disease and Infusion Associated Reaction
Status: Recruiting Condition: Pompe Disease; Hypersensitivity Reaction

Pharmacokinetics and Tolerability of Zavesca® (Miglustat) In Patients With Juvenile GM2 Gangliosidosis
Status: Active, not recruiting Condition: Gangliosidoses GM2

Miglustat in Cystic Fibrosis
Status: Completed Condition: Cystic Fibrosis

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actelion Pharms Ltd
CAPSULE;ORAL021348-001Jul 31, 2003RXYes<disabled><disabled>
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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