Posted by Michael Wonder on 14 Sep 2020
Sol-Gel Technologies announces FDA acceptance for filing of new drug application for Epsolay for the treatment of inflammatory lesions of rosacea
10 September 2020 - Potential to be first FDA-approved single-agent benzoyl peroxide prescription drug product.
Sol-Gel Technologies today announced that its new drug application for Epsolay (benzoyl peroxide), an investigational proprietary topical cream for the treatment of inflammatory lesions of rosacea, containing 5% encapsulated benzoyl peroxide, has been accepted for filing by the U.S. FDA.
The Prescription Drug User Fee Act goal date assigned by the FDA for Epsolay is 26 April 2021.
