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 locally advanced, unresectable (stage III) NSCLC. Sold as Tagrisso. Every FDA application for this active ingredient: 1 branded and 1 generic.
As of Nov 15, 2026, FDA lists 2 applications for Osimertinib Mesylate (sold as Tagrisso), first approved Nov 13, 2015, with 9 new uses approved and 0 published complete response letters.
First approved: Nov 13, 2015
Applications: 2
New uses approved: 9
Complete response letters: 0
Medicare spending, 2025: $2.30B
Orphan exclusivity until: Sep 25, 2031
First approved in the EU: Feb 1, 2016
First approved in Japan: Mar 28, 2016
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 4 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
TagrissoDrugs with a new indication for the maintenance treatment for locally-advanced, unresectable epidermal growth factor receptor (EGFR) mutation-positive non-… · AstraZeneca K.K. · May 19, 2025
TagrissoDrugs with a new indication, a new dosage, and other characteristics for postoperative adjuvant treatment for epidermal growth factor receptor (EGFR)… · AstraZeneca K.K. · Aug 24, 2022
TagrissoDrugs with a new indication for the treatment of inoperable or recurrent epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer. · AstraZeneca K.K. · Aug 21, 2018
Tagrisso, new ingredientDrugs with a new active ingredient indicated for the treatment of inoperable or recurrent epidermal growth factor receptor (EGFR) T790M mutation- positive… · AstraZeneca K.K. · Mar 28, 2016 · Review report
Clinical Trials
16 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Astrazeneca
Zydus Pharms USA Inc