Search Orphan Drug Designations and Approvals
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Generic Name: | budesonide | ||||||||||||||||
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Trade Name: | Tarpeyo | ||||||||||||||||
Date Designated: | 05/17/2010 | ||||||||||||||||
Orphan Designation: | To slow the progression of immunoglobulin A nephropathy & delay kidney failure in patients affected by the disease. | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Calliditas Therapeutics AB Kungsbron 1 Stockholm SE-111 22 Sweden The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | budesonide |
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Trade Name: | Tarpeyo | |
Marketing Approval Date: | 12/15/2021 | |
Approved Labeled Indication: | to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) > or = 1.5 g/g | |
Exclusivity End Date: | 12/15/2028 | |
Exclusivity Protected Indication* : | to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) > or = 1.5 g/g | |
2 | Generic Name: | budesonide |
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Trade Name: | Tarpeyo | |
Marketing Approval Date: | 12/20/2023 | |
Approved Labeled Indication: | to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression | |
Exclusivity End Date: | 12/20/2030 | |
Exclusivity Protected Indication* : | to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression, excluding the use provided for in the indication approved on December 15, 2021 | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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