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As of Nov 14, 2026, NDA 22572 (Mitosol), held by Glaukos, was first approved by FDA on Feb 7, 2012, with 5 approved supplements and 0 published complete response letters.
First approved: Feb 7, 2012
Review: Priority
Supplements approved: 5
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Mitosol is an antimetabolite indicated for use as an adjunct to ab externo glaucoma surgery. Mitosol is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery.
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
