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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Eliglustat Tartrate
Date Designated: 09/02/2021
Orphan Designation: Treatment of Gaucher Disease Type 1 patients who are CYP2D6 ultra-rapid metabolizers and patients whose CYP2D6 genotype cannot be determined (i.e., indeterminate metabolizers).
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Kashiv Biosciences, LLC
20 New England Avenue
Piscataway, New Jersey 08854
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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