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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: odevixibat
Trade Name: Bylvay
Date Designated: 10/31/2012
Orphan Designation: Treatment of progressive familial intrahepatic cholestasis
Orphan Designation Status: Designated/Approved
Ipsen Biopharmaceuticals, Inc.
One Main Street, 7th Floor
Cambridge, Massachusetts 02142
United States

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

Marketing approved:

1 Generic Name: odevixibat
Trade Name: Bylvay
Marketing Approval Date: 07/20/2021
Approved Labeled Indication: Treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). Limitations of use: BYLVAY may not be effective in PFIC type 2 patients with ABCB11 variants resulting in nonfunctional or complete absence of bile salt export pump protein (BSEP-3)
Exclusivity End Date: 07/20/2028 
Exclusivity Protected Indication* :  Treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). Limitations of use: BYLVAY may not be effective in PFIC type 2 patients with ABCB11 variants resulting in nonfunctional or complete absence of bile salt export pump protein (BSEP-3)
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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