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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: miglustat
Trade Name: Zavesca
Date Designated: 05/29/1998
Orphan Designation: Treatment of Gaucher disease.
Orphan Designation Status: Designated/Approved
IC-MedTech Corporation
9902 Indian Creek Lane
San Diego, California 92021
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: miglustat
Trade Name: Zavesca
Marketing Approval Date: 07/31/2003
Approved Labeled Indication: Treatment of mild to moderate Type I Gaucher disease in adults for whom enzyme replacement therapy is not a therapeutic option (e.g., due to constraints such as allergy, hypersensitivity, or poor venous access).
Exclusivity End Date: 07/31/2010 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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