Search Orphan Drug Designations and Approvals
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Generic Name: | miglustat | ||||||||||||||||
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Trade Name: | Zavesca | ||||||||||||||||
Date Designated: | 05/29/1998 | ||||||||||||||||
Orphan Designation: | Treatment of Gaucher disease. | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | miglustat |
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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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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