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# Advisors Asked About Differin OTC Switch
- URL: https://www.fdaweb.com/advisors-asked-about-differin-otc-switch/
- Published: 2016-04-14T12:00:00.000Z
- Updated: 2026-09-14T20:54:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135362

> Members of the FDA Nonprescription Drugs Advisory Committee will be asked 4/15 to comment on a Galderma sNDA for a full prescription to OTC switch for its acne drug Differin (adapelene gel 0.1%) as a once daily topical application. A staff [briefing document](http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/NonprescriptionDrugsAdvisoryCommittee/UCM495796.pdf?ref=fdaweb.com) released in advance of the meeting says that the indication that Galderma is proposing, “for the treatment of acne,” is consistent with other OTC products available for treating this condition. However, the company is also proposing “clears up acne pimples and acne blemishes,” which is a new indication in the OTC setting.  
>  
> FDA says that because there were no efficacy data submitted as part of the application, “we intend to discuss efficacy only in relation to the benefit-risk determination for the drug in the OTC setting. As such, a discussion of the exact labeled indication is beyond the scope of this meeting.”  
>  
> The briefing document says that factors advisors should consider in terms of the overall benefit-to-risk ratio of Differin for treating acne in the OTC setting are the potential for teratogenic effects, including the safety margin, human absorption data, potential for use by pregnant women, post-marketing safety data related to pregnancy, and implications for the pediatric population.  
>  
> In addition to discussing the product’s safety and efficacy, advisors are asked to comment on the proposed Drug Facts label and consumer information leaflet.