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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: laronidase
Trade Name: Aldurazyme
Date Designated: 09/24/1997
Orphan Designation: Treatment of patients with mucopolysaccharidosis-I.
Orphan Designation Status: Designated/Approved
BioMarin Pharmaceutical, Inc.
105 Digital Drive
Novato, California 94949
United States

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

Marketing approved:

1 Generic Name: laronidase
Trade Name: Aldurazyme
Marketing Approval Date: 04/30/2003
Approved Labeled Indication: Treatment for patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms
Exclusivity End Date: 04/30/2010 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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