Lowers the risk of periprocedural myocardial infarction (MI), repeat coronary…. ANDA 213551, held by Gland. Cangrelor.
As of Nov 13, 2026, ANDA 213551 (Cangrelor), held by Gland, was first approved by FDA on Aug 11, 2025, with 0 approved supplements and 0 published complete response letters.
Cangrelor for injection 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 11, 2025 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cangrelor50MG/VIAL · powder;intravenous | Cangrelor | Rx |
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
