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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  4-pyridinylmethyl 3(4-chlorophenyl)adamantine carboxamide
Trade Name:  Yeliva
Date Designated:  03/30/2017
Orphan Designation:  Treatment of cholangiocarcinoma
Orphan Designation Status:  Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Marketing Approval Date:  N/A
Approved Labeled Indication:  
Exclusivity End Date:    N/A
RedHill Biopharma Ltd.
21 Ha'arba'a Street
Tel Aviv-Yafo

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