UroGen gets FDA nod for extending duration of Jelmyto admixture

Sep. 28, 2022 11:28 AM ETUroGen Pharma Ltd. (URGN)By: Ravikash, SA News Editor

FDA Approved Products or Drugs

Olivier Le Moal

  • UroGen Pharma (NASDAQ:URGN) stock rose ~4% on Sept. 28 after the company said that the U.S. Food and Drug Administration (FDA) authorized an extension of the in-use period for Jelmyto (mitomycin) for pyelocalyceal solution admixture from 8 hours to 96 hours after reconstitution of the product.
  • Jelmyto is used to treat low-grade, upper-tract urothelial cancer (LG UTUC).
  • "This extension expands access to JELMYTO and gives our customers greater flexibility in choosing when to mix and schedule instillations," said UroGen Chief Commercial Officer Jeff Bova.

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