Tuesday, July 7, 2026
42 days away
Drug Information
- Application Type
- sBLA
- FDA Designations
- BreakthroughPriority Review
- Indication
- HER2-positive early breast cancer with residual invasive disease (DESTINY-Breast05)
Filing Details
- Company
- AstraZeneca PLC →
- Stock Ticker
- AZN
- SEC CIK
- 0000901832
- Source
- Company IR →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Explore AstraZeneca PLC
View AstraZeneca PLC's full pipeline, approved drugs, and clinical trials.
Data sourced from SEC EDGAR filings. Last updated: 2026-04-20. Report an issue