What changed › 2026-08-27
NDA215866
Detected 2026-08-27 in the approvals record for tirzepatide, by comparing that day’s fetch against the previous one.
A new row in Drugs@FDA is the regulator's own record of an action. Efficacy supplements are where new indications land; labeling supplements are where new safety language does.
What changed
| Change | Field | Value |
|---|---|---|
| new trial registered | Efficacy |
What the record says now
- Application
- NDA215866
- Brands
- Mounjaro, Mounjaro Kwikpen
- Label effective
- 2026-08-27
- Approved for
- cardiovascular disease, type 2 diabetes
See tirzepatide · the source record.
The previous value above is not recoverable from the source. Both ClinicalTrials.gov and the FDA revise records in place, keeping no public history, which is why this site keeps its own.