FDA Authorizes Extension of In-Use Period for UroGen Pharma’s JELMYTO Admixture

 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the U.S. Food and Drug Administration (FDA) has authorized an extension of the in-use period for JELMYTO® (mitomycin) for pyelocalyceal solution admixture from 8 hours to 96 hours (four days) following reconstitution of the product. This extension is significant and has implications for all stakeholders including physicians, hospitals, pharmacists and the adult patients who use UroGen’s medicine to treat low-grade, upper-tract urothelial cancer (LG UTUC).

https://finance.yahoo.com/news/fda-authorizes-extension-period-urogen-120000922.html