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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: humanized IgG4 Monoclonal Antibody against total complement component 1, subcomponent s (C1s)
Date Designated: 08/17/2017
Orphan Designation: Treatment of bullous pemphigoid (BP).
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Bioverativ USA Inc.
225 Second Avenue
Waltham, Massachusetts 02451
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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