ODINSIGNAL JOURNAL · NEWS & EVENTS
FDA Target Date Set for IGALMI At‑Home Indication – Nov 14 2026
The FDA has a November 14 2026 target date to decide on an at‑home use indication for IGALMI (dexmedetomidine sublingual film).
At a glance
- Date
- November 14, 2026
- Participants
- FDA
The U.S. Food and Drug Administration has a target PDUFA date of November 14, 2026 for a supplemental at‑home use indication of IGALMI, the dexmedetomidine sublingual film. Source: FDA approval decisions this week.
IGALMI is listed on the FDA’s decision calendar, but as of 5 Nov 2026 no approval or complete response letter has been issued. See the FDA decision calendar.
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