Used in scans for known or suspected coronary artery disease (CAD). NDA 215168, held by Ge Hlthcare. Flurpiridaz F-18.
As of Nov 14, 2026, NDA 215168 (Flyrcado), held by Ge Hlthcare, was first approved by FDA on Sep 27, 2024, with 0 approved supplements and 0 published complete response letters.
FLYRCADO is indicated for positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress (pharmacologic or exercise) in adult patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia and infarction.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 27, 2024 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Flyrcado5-55mCi/ML · solution;intravenous | Flurpiridaz F-18 | RxReference drug |
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
