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Galderma's Acne Drug Switch Gets Unanimous NDAC Support

 
• By Malcolm Spicer

If approved by FDA, the product, to be marketed as Differin Gel, would be the first OTC drug available in the US that contains an ingredient in the retinoid class – adapalene 0.1 gel. Discussion at the April 15 meeting of FDA's Nonprescription Drugs Advisory Committee focused largely on the issue of self-selection among pregnant women.

FDA's Nonprescription Drugs Advisory Committee voted unanimously April 15 to recommend approval of Galderma Laboratories L.P.'s first-in-class OTC switch of adapalene gel 0.1% acne treatment.

During the meeting in Gaithersburg, Md

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