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Lowers the risk of periprocedural myocardial infarction (MI), repeat coronary…. NDA 204958, held by Chiesi. Cangrelor.
As of Nov 13, 2026, NDA 204958 (Kengreal), held by Chiesi, was first approved by FDA on Jun 22, 2015, with 3 approved supplements and 0 published complete response letters.
First approved: Jun 22, 2015
Review: Standard
Supplements approved: 3
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
KENGREAL is indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y 12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.
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
