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UGN-101 Approval Status

FDA Approved: No
Brand name: UGN-101
Generic name: mitomycin
Dosage form: Gel
Company: UroGen Pharma Ltd.
Treatment for: Urothelial Carcinoma

UGN-101 (mitomycin gel) for instillation is an investigational drug formulation of mitomycin in development for the treatment for patients with low-grade upper tract urothelial cancer.

Development Status and FDA Approval Process for UGN-101

Dec 19, 2019UroGen Pharma Announces FDA Filing Acceptance and Priority Review of U.S. New Drug Application (NDA) for UGN-101
Dec 17, 2018UroGen Pharma Initiates Rolling Submission of New Drug Application (NDA) for UGN-101 for the Treatment of Low-Grade Upper Tract Urothelial Cancer

Further information

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