FDA Advisory Panel Recommends OTC Adapalene

04/19/2016

The FDA Nonprescription Drugs Advisory Committee (NDAC) voted 16-0 on April 15 that adapalene gel 0.1% (Differin Gel), a long-approved prescription topical retinoid for acne is safe for over-the-counter (OTC) use. This recommendation is a first-in-class switch.

While the NDAC agreed that the safety profile and data for adapalene gel .01% were adequate to allow the product to be sold over-the-counter, the panel disagreed on appropriate labeling. The data was submitted by Galderma Laboratories, L.P. to support supplemental new drug application (sNDA) 20-380, for OTC marketing of adapalene gel 0.1% in patients 12 years and older.

The issue of labeling was debated on several issues, including the use and safety in pregnant women and the additional labeling regarding photosensitivity.

 Although the FDA is not required to follow the advice of its advisory committees, the agency often does approve the recommendations.