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Warning letters, 483s, Recalls, Import Alerts, Audit observations
The USFDA has Approved the NDA for ADQUEY (Difamilast 1%) ointment for the treatment of atopic dermatitis (eczema) in February 2026. In a press release, Aurobindo Pharma announced the approval of the NDA for ADQUEY by its wholly owned stepdown subsidiary Acrotech Biopharma Inc., in collaboration with Otsuka Pharmaceutical Co., Ltd.
ADQUEY is a novel, non-steroidal, topical phosphodiesterase 4 (PDE4) inhibitor for the treatment of atropic dermatitis, a common and chronic condition that causes itchy, dry, and inflamed skin.
The Difamilast 1% ointment is already approved in Japan in 2021 under the name Moizerto (by Otsuka Pharmaceutical).
Press Release Aurobindo – Approval of ADQUEY in US (February 2026)
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