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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: pegloticase
Trade Name: Krystexxa
Date Designated: 02/21/2001
Orphan Designation: To control the clinical consequences of hyperuricemia in patients with severe gout in whom conventional therapy is contraindicated or has been ineffective
Orphan Designation Status: Designated/Approved
Horizon Therapeutics Ireland DAC
70 St. Stephen’s Green
Dublin 2 D02 E2X4
Ireland

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

Marketing approved:

1 Generic Name: pegloticase
Trade Name: Krystexxa
Marketing Approval Date: 09/14/2010
Approved Labeled Indication: Treatment of chronic gout in adult patients refractory to conventional treatment
Exclusivity End Date: 09/14/2017 
Exclusivity Protected Indication* :  
Generic Name: pegloticase
Trade Name: Krystexxa
Date Designated: 02/21/2001
Orphan Designation: To control the clinical consequences of hyperuricemia in patients with severe gout in whom conventional therapy is contraindicated or has been ineffective.
Orphan Designation Status: Designated/Approved
Horizon Therapeutics Ireland DAC
70 St. Stephen’s Green
Dublin 2 D02 E2X4
Ireland

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

Marketing approved:

1 Generic Name: pegloticase
Trade Name: Krystexxa
Marketing Approval Date: 07/07/2022
Approved Labeled Indication: Treatment of chronic gout in adult patients refractory to conventional therapy
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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