FDA Approves First OTC Retinoid Acne Treatment

The Food and Drug Administration (FDA) has approved Differin Gel (adapalene Galderma) 0.1% for over-the-counter (OTC) treatment of acne in patients aged ≥12 years.

Differin Gel 0.1%, a retinoid, was initially approved in 1996 for prescription treatment of acne vulgaris. This approval marks the first retinoid acne treatment to be made available OTC. The 0.3% strength still remains a prescription product. 

The support for its OTC marketing approval was based on 1996–2010 post-marketing safety data, data from consumer studies (a label comprehension study, self-selection study, actual use trial), and data from a maximal use trial. In general, data from the consumer studies indicated that consumers were able to understand the information on the OTC label, appropriately determine whether the product was right for them, and use it properly. Data from the maximal use trial showed that drug absorption over a large surface area (eg, face, shoulders, upper back, chest) was limited, which supported the safe use of the gel OTC. 

Differin is also available as a 0.1% cream and 0.1% lotion.

For more information call (817) 961-5000 or visit Differin.com.