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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Buffered Ursodeoxycholic Acid
Date Designated:  09/03/2004
Orphan Designation:  Treatment of pruritus in patients with Alagille Syndrome
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Digestive Care, Inc.
1120 Win Drive
Bethlehem, Pennsylvania 18017
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.