mitomycin intravesical solution (Zusduri, UGN-102): FDA status

Approved Approved Jun 12, 2025. Indication: Recurrent low grade intermediate risk NMIBC. Company: UroGen Pharma.

Regulatory history

• Jun 12, 2025: Approved. FDA approved UGN-102 mitomycin intravesical solution Zusduri as nonsurgical treatment for recurrent low grade NMIBC. Targeted Oncology
• May 21, 2025: Advisory committee. FDA ODAC voted against the risk benefit profile of UGN-102 for recurrent low grade intermediate risk NMIBC. OncLive
• Oct 15, 2024: FDA accepted for review. FDA accepted UroGen's new drug application for UGN-102 in NMIBC. Business Wire
• Jan 1, 2024: Application filed. UroGen initiated submission of a rolling NDA for UGN-102, submitting the CMC section in January 2024. sec.gov

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