Sol-Gel Technologies provides update on delayed FDA review of Epsolay, a proposed treatment for rosacea.

Sol-Gel Technologies, Ltd. announced an update regarding the FDA approval process for Epsolay (benzoyl peroxide) 5% topical cream for the treatment of Inflammatory lesions of rosacea in adults. In September of 2020, Sol-Gel was informed by the FDA that the PDUFA goal date for Epsolay is April 26, 2021. Subsequently, the COVID-19 pandemic restricted the FDA’s ability to conduct pre-approval inspections. In our most recent written communication with the FDA regarding Epsolay, the final content of the labeling was discussed and agreed to. As of today, Sol-Gel has received no notification from the FDA, but did receive email confirmation that that action on the NDA for Epsolay could not be taken since a pre-approval inspection of the production site of EpsolayY still needs to be conducted.