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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
Date Designated: 11/12/2008
Orphan Designation: Treatment of the neurological manifestations of Niemann-Pick disease,type C.
Orphan Designation Status: Designated/Withdrawn
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Actelion Pharmaceuticals Ltd
Innovation Centre
Allschwil
Switzerland

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

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