Monday, June 15, 2026
Approved
approved Note: Approved 2026-05-15 as BAXFENDY (ORIG NDA219878). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 31d from the PDUFA date. MEDIUM match accepted by owner review 2026-10-06: it is the drug's first-ever (ORIG) approval, so it can only be this decision.
Drug Information
- Drug Name
- Baxdrostat (CT.gov)
- Application Type
- NDA
- FDA Designations
- BreakthroughFast TrackPriority Review
- Indication
- Hard-to-control hypertension (add-on therapy)
- Approved As
- Baxdrostat
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
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Data sourced from SEC EDGAR filings. Last updated: 2026-04-20. Report an issue