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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: bispecific antibody targeting interleukin 4 (IL-4) and interleukin 13 (IL-13)
Date Designated: 09/14/2011
Orphan Designation: Treatment of idiopathic pulmonary fibrosis.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 02/21/2018
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sanofi US Services, Inc., A SANOFI COMPANY
55 Corporate Drive
Mailstop: 55C-300
Bridgewater, New Jersey 08807
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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