UroGen Announces FDA Acceptance Of Its New Drug Application For UGN-102 For Intravesical Solution

Benzinga · 10/15 20:32
  • PDUFA goal date set for June 13, 2025
  • UGN-102 would be the first FDA-approved medicine for LG-IR-NMIBC, if approved

UroGen Pharma Ltd. (NASDAQ:URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced U.S. Food and Drug Administration (FDA) acceptance of the New Drug Application (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 (LG-IR-NMIBC). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 13, 2025.