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As of Nov 14, 2026, NDA 22450 (Ofirmev), held by Mallinckrodt Hosp, was first approved by FDA on Nov 2, 2010, with 6 approved supplements and 1 published complete response letter.
First approved: Nov 2, 2010
Review: Priority
Supplements approved: 6
Complete response letters: 1
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 7 submissions below
Jan 27, 2017
Supplement 10Efficacy (new indication or use) · Priority review
Ofirmev1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intravenous
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
