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As of Nov 15, 2026, NDA 205755 (Zykadia), held by Novartis, was first approved by FDA on Apr 29, 2014, with 13 approved supplements and 0 published complete response letters.
First approved: Apr 29, 2014
Review: Priority
Supplements approved: 13
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 14 submissions below
Dec 21, 2017
Supplement 10Efficacy (new indication or use) · 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
