UroGen Pharma: FDA Accepts UGN-102 NDA For Treatment Of Low-Grade Bladder Cancer

(RTTNews) - UroGen Pharma Ltd. (URGN) said that the U.S. Food and Drug Administration accepted the New Drug Application or NDA for investigational drug UGN-102 (mitomycin) for intravesical solution. UGN-102 could become the first FDA-approved medicine for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 13, 2025.

UGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently under regulatory review for approval in the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer. The U.S. market for low-grade intermediate-risk non-muscle invasive bladder cancer that UGN-102 can address, if approved, is valued at about $5 billion.

For More Such Health News, visit rttnews.com.