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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Trehalose + miglustat
Date Designated: 08/10/2020
Orphan Designation: Treatment of CLN Batten disease
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Beyond Batten Disease Foundation
P.O. Box 50221
Austin, Texas 78763
United States

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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