Search Orphan Drug Designations and Approvals
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Generic Name: | mitomycin | ||||||||||||||||
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Trade Name: | Jelmyto | ||||||||||||||||
Date Designated: | 09/08/2014 | ||||||||||||||||
Orphan Designation: | Treatment of upper tract urothelial cell cancers (transitional cell carcinoma of the renal pelvis and ureter) | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
UroGen Pharma, Ltd. 9 Ha'Ta'asiya St., POB 2397 Ra'anana Israel 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: | mitomycin |
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Trade Name: | Jelmyto | |
Marketing Approval Date: | 04/15/2020 | |
Approved Labeled Indication: | JELMYTO¿ is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC) | |
Exclusivity End Date: | 04/15/2027 | |
Exclusivity Protected Indication* : | Indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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