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Balversa FDA Approval History

FDA Approved: Yes (First approved April 12, 2019)
Brand name: Balversa
Generic name: erdafitinib
Dosage form: Tablets
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Urothelial Carcinoma

Balversa (erdafitinib) is a once-daily, oral, pan-fibroblast growth factor receptor for the treatment of patients with locally advanced or metastatic urothelial cancer.

Development Timeline for Balversa

DateArticle
Apr 12, 2019ApprovalFDA Approves Balversa (erdafitinib) for the Treatment of Metastatic Bladder Cancer
Sep 18, 2018Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Erdafitinib for the Treatment of Metastatic Urothelial Cancer
Jun  3, 2018Erdafitinib Phase 2 Study Results Show Promise in the Treatment of Metastatic Urothelial Cancer
Mar 15, 2018Janssen Announces U.S. FDA Breakthrough Therapy Designation for Erdafitinib in the Treatment of Metastatic Urothelial Cancer

Further information

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