Background Analysis: US FDA Advisory Committee to Review Application for Over the Counter Use of Galderma’s Adapalene Gel for Acne – APR 15, 2016 (NDAC)

The US FDA has scheduled a Nonprescription Drugs Advisory Committee (NDAC) meeting for Friday, April 15, 2016 to 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 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