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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Cystic fibrosis transmembrane conductance regulator
Date Designated: 01/14/1992
Orphan Designation: For cystic fibrosis transmembrane conductance regulator protein replacement therapy in cystic fibrosis patients.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Genzyme Corporation
One Mountain Road
P.O. Box 9322
Framingham, Massachusetts 01701
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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