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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
Trade Name: CERDELGA
Date Designated: 09/17/2008
Orphan Designation: Treatment of Type I Gaucher disease
Orphan Designation Status: Designated/Approved
Genzyme Corporation
500 Kendall Street
Cambridge, Massachusetts 02142
United States

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

Marketing approved:

1 Generic Name: eliglustat
Trade Name: CERDELGA
Marketing Approval Date: 08/19/2014
Approved Labeled Indication: Long-term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test.
Exclusivity End Date: 08/19/2021 
Exclusivity Protected Indication* :  Long-term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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