USFDA13 Feb 2026, 09:32 pm
Aurobindo Pharma Subsidiary Acrotech Biopharma Receives USFDA Approval for ADQUEY™ (difamilast 1%) Ointment
AI Summary
Acrotech Biopharma Inc., a stepdown subsidiary of Aurobindo Pharma Ltd, has announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ADQUEY™ (difamilast 1%) ointment. The topical treatment is for the treatment of mild-to-moderate atopic dermatitis (AD) in adults and pediatric patients aged 2 and older. ADQUEY is a novel, non-steroidal, topical phosphodiesterase 4 (PDE4) inhibitor.
Key Highlights
- Acrotech Biopharma Inc., a subsidiary of Aurobindo Pharma Ltd, received USFDA approval for ADQUEY™ (difamilast 1%) ointment.
- The ointment is for the topical treatment of mild-to-moderate atopic dermatitis (AD) in adults and pediatric patients aged 2 and older.
- ADQUEY is a novel, non-steroidal, topical phosphodiesterase 4 (PDE4) inhibitor.
- The approval provides a new non-steroidal, topical treatment option for the millions of Americans living with atopic dermatitis.
- The safety profile of ADQUEY AD was consistent across all three trials, with the most common adverse reactions being nasopharyngitis.