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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: sapropterin
Trade Name: Kuvan
Date Designated: 01/29/2004
Orphan Designation: Treatment of hyperphenylalaninemia
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: sapropterin
Trade Name: Kuvan
Marketing Approval Date: 12/13/2007
Approved Labeled Indication: Indicated to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Kuvan is to be used in conjunction with a Phe-restricted diet.
Exclusivity End Date: 12/13/2014 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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