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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Taliglucerase alfa
Trade Name: ELELYSO for injection
Date Designated: 09/03/2009
Orphan Designation: Treatment of Gaucher's disease
Orphan Designation Status: Designated/Approved
Pfizer, Inc.
235 East 42nd Street
New York, New York 10017
United States

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

Marketing approved:

1 Generic Name: Taliglucerase alfa
Trade Name: ELELYSO for injection
Marketing Approval Date: 05/01/2012
Approved Labeled Indication: Use as long-term enzyme replacement therapy in patients with Type 1 Gaucher disease
Exclusivity End Date: N/A  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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