Acrotech Biopharma Inc., the U.S.-based step-down subsidiary of India-headquartered Aurobindo Pharma Ltd., has secured approval from the U.S. Food and Drug Administration for ADQUEY™. The approval marks a significant advancement in the company’s dermatology portfolio.
ADQUEY™ is a difamilast 1% ointment for mild-to-moderate atopic dermatitis.
The treatment addresses a chronic inflammatory skin condition affecting millions worldwide. The FDA approved the product for adults and children aged two years and older.
This broad indication strengthens its relevance in paediatric and adult dermatology care. Atopic dermatitis causes persistent itching, redness, dryness, and recurring skin inflammation. Many patients require long-term management to control flare-ups effectively.
Addressing long-term eczema management
ADQUEY™ offers a non-steroidal topical treatment option. Dermatologists often seek alternatives to prolonged corticosteroid use. Long-term steroid therapy can lead to skin thinning and other side effects. Difamilast works by inhibiting phosphodiesterase 4, an enzyme linked to inflammation. This mechanism reduces inflammatory responses directly within affected skin areas.
Clinical validation supports approval
Clinical studies demonstrated meaningful improvement in skin clearance and symptom relief. Patients experienced reductions in itching and visible lesion severity. The trials supported both safety and efficacy across eligible age groups. These outcomes contributed to the FDA’s positive regulatory decision.
The product was developed by Acrotech Biopharma Inc., a step-down subsidiary of Aurobindo Pharma. The approval represents Aurobindo’s first innovative NDA success in dermatology. This milestone signals a strategic shift beyond traditional generic formulations.
Expanding specialty focus in skin science
Aurobindo continues expanding into speciality and differentiated therapeutic segments. Dermatology remains a high-growth category driven by rising diagnosis rates. Demand for targeted, safer topical therapies continues to increase globally.
With this approval, the company strengthens its presence in the U.S. dermatology market. Acrotech plans to commercialise ADQUEY™ across the United States.
The launch will provide dermatologists with a new non-steroidal treatment option. Patients with chronic eczema may now access an additional evidence-based therapy.
The approval underscores Aurobindo’s growing capabilities in innovative skin science.
It also reinforces the company’s commitment to addressing unmet dermatological needs.