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Profile for Tradename: ZAVESCA

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Zavesca is a drug marketed by Actelion Pharms Ltd and is included in one NDA. It is available from one supplier.

The generic ingredient in ZAVESCA is miglustat. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the miglustat profile page.

Summary for Tradename: ZAVESCA

Suppliers / Packagers: see list1

Pharmacology for Tradename: ZAVESCA

Clinical Trials for: ZAVESCA

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

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

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

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

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

Two Period / Two Treatment Cross-over to Assess the Effect of Florastor® on Gastrointestinal Tolerability, Safety, and PK in Healthy Subjects Receiving Zavesca®
Status: Completed Condition: Diarrhea

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

Does a Nasal Instillation of Miglustat Normalize the Nasal Potential Difference in Cystic Fibrosis Patients ?
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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ISSN: 2162-2639

Preferred citation:

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

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