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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: mitomycin
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
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.

Marketing approved:

1 Generic Name: mitomycin
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).
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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