Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC). NDA 16885, held by Esteve. Mitotane.
As of Nov 13, 2026, NDA 16885 (Lysodren), held by Esteve, was first approved by FDA on Jul 8, 1970, with 22 approved supplements and 0 published complete response letters.
First approved: Jul 8, 1970
Review: Priority
Supplements approved: 22
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
LYSODREN is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC).
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
