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Acne Drug Switch Study Stirs FDA Doubts About Pregnant Women's Self-Selection

This article was originally published in The Tan Sheet

Executive Summary

The NDAC met April 15 to make recommendations on Galderma's first-in-class switch proposal for adapalene gel 0.1% indicated for treatment of acne in consumers ages 12 and older. FDA told the committee Galderma's study did not "demonstrate that pregnant or breastfeeding women could adequately self-select to use the product."


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