Friday, May 29, 2026
3 days away
Drug Information
- Drug Name
- Afrezza (Technosphere Insulin) (CT.gov)
- Application Type
- sBLA
- Indication
- Pediatric diabetes, ages 4-17 (type 1 or type 2)
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
Explore MannKind Corporation
View MannKind Corporation's full pipeline, approved drugs, and clinical trials.
Data sourced from SEC EDGAR filings. Last updated: 2026-04-10. Report an issue