Source: FDA, National Drug Code (US) Revision Year: 2026
ADQUEY (difamilast) ointment contains difamilast as the active ingredient. Difamilast, is a phosphodiesterase-4 (PDE-4) inhibitor.
Difamilast is described chemically as N-({2-[4-(Difluoromethoxy)-3-(propan-2-yloxy)phenyl]-1,3-oxazol-4-yl}methyl)-2-ethoxybenzamide. The empirical formula is C23H24F2N2O5 and the molecular weight is 446.44 g/mol.
The structural formula is represented below:
Difamilast occurs as white (or practically white) crystals or crystalline powder. It is very soluble in N-methylpyrrolidone, freely soluble in methanol and ethanol (99.5), and practically insoluble in water. It shows crystal polymorphism.
Each gram of ADQUEY contains 1% difamilast (w/w) in a wax-based, white to off-white ointment containing the following inactive ingredients: mineral oil, paraffin, propylene carbonate, white petrolatum, and white wax.
| Dosage Forms and Strengths |
|---|
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Ointment: 1% (10 mg of difamilast per gram) of white to off-white ointment. |
| How Supplied |
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ADQUEY (difamilast) ointment, 1% is a white to off-white ointment supplied in the following packages:
(Made in Canada) Manufactured for: Acrotech Biopharma Inc, East Windsor, NJ 08520 USA |
| Drug | Countries | |
|---|---|---|
| ADQUEY | United States |
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