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As of Nov 14, 2026, NDA 209176 (Radicava), held by Shionogi, was first approved by FDA on May 5, 2017, with 5 approved supplements and 0 published complete response letters.
First approved: May 5, 2017
Review: Standard
Supplements approved: 5
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 6 submissions below
Date
Submission
Status
Documents
May 5, 2017
Original applicationNew molecular entity · Standard review
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
