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Upcoming FDA decision · September 30, 2026

VNDA PDUFA date: FDA decision expected September 30, 2026

The FDA is expected to decide on this application from Vanda Pharmaceuticals Inc. by the PDUFA target action date of September 30, 2026. For Non-24-hour sleep-wake disorder in the blind. sNDA filing. Extracted from SEC filing: 8-K

A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.

September 30
Target action date
NDA
Stage
Detected
Date confidence
FDA designations