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Pfizer Reports FDA Approval For Expanded Indication Of EUCRISA - Quick Facts

Pfizer Inc. (PFE) announced the U.S. FDA has approved the company's supplemental New Drug Application for EUCRISA ointment, 2%, extending the lower age limit from 24 months down to 3 months in children with mild-to-moderate atopic dermatitis. The company said the supplemental approval makes EUCRISA the first and only steroid-free, topical prescription medication for mild-to-moderate atopic dermatitis patients as young as 3 months of age.

The FDA approval for the expanded indication of EUCRISA was supported by data from a Phase 4, open-label, clinical study.

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