Briefing Summary: US FDA Posts Advisory Committee Materials for a Review of Proposed Over the Counter Use of Galderma’s Adapalene Gel for Acne – APR 15, 2016 (NDAC)

The US FDA has posted details, including company and FDA Briefing Materials, for the Friday, April 15, 2016 Nonprescription Drugs Advisory Committee (NDAC) meeting. The Committee will discuss data submitted by Galderma Laboratories, L.P. (Galderma) to support supplemental new drug application (sNDA) 20-380, for over-the-counter (OTC) marketing of Differin (adapalene gel 0.1%). The proposed OTC use is for the treatment of acne and to clear up acne pimples and acne blemishes. Galderma proposes to label the product for individuals 12 years and older. The Committee will be asked to consider whether data support an acceptable risk/benefit profile for the nonprescription use of adapalene gel 0.1% by OTC consumers.

See the SAC Tracker report