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FDA Medication Tracker

← All approvals · Immune & inflammatory · 2026

Adquey (difamilast)

The FDA approved Adquey (difamilast) on February 12, 2026 to treat mild to moderate atopic dermatitis.
Brand name
Adquey
Generic name
difamilast
FDA approval date
February 12, 2026
Approved use (FDA wording)
To treat mild to moderate atopic dermatitis
Company
Acrotech Biopharma
Application
NDA219474
Dosage form / route
OINTMENT · TOPICAL
Drug class (EPC)
Phosphodiesterase 4 Inhibitor [EPC]
Boxed warning on label
Not listed
Category on this site
Immune & inflammatory

Indications and usage, from the FDA label

1 INDICATIONS & USAGE ADQUEY is indicated for the topical treatment of adults and pediatric patients 2 years of age and older with mild to moderate atopic dermatitis. ADQUEY is a phosphodiesterase 4 inhibitor indicated for the topical treatment of adults and pediatric patients 2 years of age and older with mild to moderate atopic dermatitis. (1)

Official sources

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