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US FDA accepts NDA for reformulated actinic keratosis drug

This article was originally published in Scrip

Executive Summary

An NDA for Graceway Pharmaceuticals' reformulated Aldara (imiquimod 3.75%) has been accepted by the US FDA. Whereas a 5% imiquimod topical formulation is currently approved for non-hyperkeratotic, non-hypertrophic actinic keratosis (AK) on the face and scalp in immunocompetent adults, the company is now seeking approval for clinically typical AK lesions on patients with extensive disease.






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