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FDA approval · 2025-09-09

FDA Approved: INLEXZO — Original Application (Janssen Biotech, Inc)

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Summary

FDA approved INLEXZO, gemcitabine delivered intravesically, under Janssen’s original NDA for bladder cancer.

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Diseases / indications

Drugs mentioned

  • INLEXZO (Gemcitabine intravesical)

Snippet

ORIG AP for INLEXZO (GEMCITABINE INTRAVESICAL)