Friday, May 29, 2026
Approved
approved Note: Approved 2026-05-29 as AFREZZA (SUPPL BLA022472). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-07-30; 0d from the PDUFA date.
Drug Information
- Drug Name
- Afrezza (Technosphere Insulin) (CT.gov)
- Application Type
- sBLA
- Indication
- Pediatric diabetes, ages 4-17 (type 1 or type 2)
- Approved As
- Afrezza (Technosphere Insulin)
Filing Details
- Company
- MannKind Corporation →
- Stock Ticker
- MNKD
- SEC CIK
- 0000899460
- 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: 2026-04-10. Report an issue