Used in scans for recurrent or metastatic breast cancer. NDA 212155, held by Ge Healthcare. Fluoroestradiol F-18.
As of Nov 13, 2026, NDA 212155 (Cerianna), held by Ge Healthcare, was first approved by FDA on May 20, 2020, with 2 approved supplements and 0 published complete response letters.
CERIANNA is indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 20, 2020 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cerianna50ML (4-100mCi/ML) · solution;intravenous | Fluoroestradiol F-18 | RxReference drug |
| May 6, 2024 | Supplement 21Labeling · Standard review | Approved | |
| Apr 6, 2022 | Supplement 14Labeling · Standard review | Approved | None posted |
| May 20, 2020 | Original applicationNew molecular entity · Standard review | Approved |
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
