Anaphylm (epinephrine sublingual) PDUFA Date (Aquestive Therapeutics)

Name: FDA PDUFA Decision: Anaphylm (epinephrine sublingual)
Start: 2026-01-31

FDA PDUFA decision date for Anaphylm (epinephrine sublingual) is January 31, 2026. Developed by Aquestive Therapeutics. Indication: Type 1 allergic reactions / anaphylaxis. Current status: CRL.

Indication

Type 1 allergic reactions / anaphylaxis

Regulatory details

Company: Aquestive Therapeutics
Therapeutic area: Immunology
Application type: NDA
Review type: Standard
PDUFA date: 2026-01-31
Outcome: CRL

Anaphylm (epinephrine sublingual) PDUFA Date — Aquestive Therapeutics