Saturday, December 12, 2026
200 days away
Drug Information
- Drug Name
- Imsidolimab (CT.gov)
- Application Type
- BLA
- Indication
- Generalized Pustular Psoriasis
Filing Details
- Company
- Vanda Pharmaceuticals Inc. →
- Stock Ticker
- VNDA
- SEC CIK
- 0001347178
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: 2026-05-10. Report an issue