FDA approved the original new drug application for AXUMIN on May 27, 2016, sponsored by BLUE EARTH. FDA classed that submission a new molecular entity, which makes it the first approval of fluciclovine f-18 in any product. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- NDA208054
- Sponsor
- BLUE EARTH
- Original approval
- Review
- priority review
- Submission class
- Type 1 - New Molecular Entity
- Active ingredient
- fluciclovine f-18
Browse every approval whose brand starts with A, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| fluciclovine f-18 9-221mCi/ML | SOLUTION | INTRAVENOUS | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
FDA’s record shows no approved efficacy supplement on this application.
FDA records other approved supplements on this application, by the class code it assigns them: Manufacturing (CMC) 2 · Labeling 1. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
Other approvals to BLUE EARTH
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