FDA Approves OTC Differin Gel 0.1% for Acne


Earlier this month, the FDA approved—effective immediately—adapalene (Differin®) 0.1% gel to be sold as an over-the-counter (OTC) topical treatment for acne for patient ages 12 and up.

What is Differin gel?

Adapalene (Differin®) is a third-generation retinoid-class topical agent indicated as the first line treatment for acne—acne vulgaris—of all severity with additional off label indication for keratosis pilaris. Topical retinoids—a vitamin A derivative— works to treat acne by modifying the epithelial growth, cellular differentiation, keratinization, and inflammatory processes of skin cells.

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Why is this significant?

Differin® 0.1% gel is the first of the retinoid class to become readily available for consumer purchase at drug stores—without physician prescription.  This is a dream come true for 50 million Americans suffering from acne since prescribed acne topical skin products can cost an arm and a leg.  This transition will produce the following benefits for consumers.

  • OTC price reduction may directly facilitate consumer savings and keep more money in our pockets. Adapalene prescription products can cost anywhere from $196.561 (45 g tube of Adapalene 0.1% gel) to $634.921 (45 g tube of Differin®1% cream) per month before insurance.  The precise amount saved will vary, based on the product’s pricing, set by the manufacturer—Galderma Laboratories.
  • Notable increased in access to retinoid topical products can eliminate long waits at the doctor’s office, eliminate medical costs, and increase patient compliance.

Is is safe to be an OTC item?

Evidence to support Differin® Gel’s safety and efficacy as an OTC product are established with “post-marketing studies (from 1996-2016), data from consumer studies, and data from a maximal use trial”.2   Consumer studies concluded that consumers are capable of selecting an appropriate OCT medication product for acne, and demonstrates adequate understanding of information provided to them on the OTC labels.

Other topical retinoid derivatives used for acne

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  1. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm510362.htm
  2. Lexicomp Online





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