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Vistogard Approval History

FDA Approved: Yes (First approved December 11, 2015)
Brand name: Vistogard
Generic name: uridine triacetate
Dosage form: Oral Granules
Company: Wellstat Therapeutics Corporation
Treatment for: Fluorouracil Overdose and Capecitabine Overdose

Vistogard (uridine triacetate) is a pyrimidine analog indicated for the emergency treatment of adults and children who receive an overdose of the cancer treatments fluorouracil or capecitabine.

Development History and FDA Approval Process for Vistogard

DateArticle
Dec 11, 2015Approval FDA Approves Vistogard (uridine triacetate) for Emergency Treatment for Overdose of Certain Types of Chemotherapy
Sep 10, 2015Wellstat Therapeutics’ NDA for Uridine Triacetate as Antidote to Overexposure to Chemotherapy Drug 5-Fluorouracil (5-FU) Accepted for Review by FDA

Further information

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