mitomycin intravesical solution (UGN-103): FDA status

Under review FDA decision date Dec 18, 2026. Indication: Recurrent low grade intermediate risk NMIBC (next generation formulation). Company: UroGen Pharma.

Regulatory history

• Dec 18, 2026: Decision date set. FDA accepted UroGen NDA for UGN-103 next generation mitomycin formulation and assigned PDUFA target action date of December 18 2026 nuaxia.com
• Aug 17, 2026: Application filed. UroGen submitted an NDA to FDA seeking approval of UGN-103 for recurrent LG IR NMIBC. urologytimes.com

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