FDA Accepts NDA for UGN-103 in Recurrent LG-IR-NMIBC
“FDA acceptance of the UGN-103 NDA advances our vision for the next evolution of our portfolio and our continued commitment to transforming the treatment of recurrent LG-IR-NMIBC,” said Liz Barrett, President and CEO, UroGen. “Building on our experience with ZUSDURI (mitomycin) for intravesical solution, UGN-103 combines our proprietary RTGel® technology with a novel mitomycin formulation, which leverages a streamlined manufacturing process and simplified reconstitution. We look forward to working closely with the FDA during its review and remain focused on delivering innovative treatment options for people living with this highly recurrent disease.”
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