Benzinga | Apr 27, 2021 10:04AM EDT

Sol-Gel Technologies Provides Update On FDA Review Of EPSOLAY

Sol-Gel Technologies, Ltd. (NASDAQ:SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced an update regarding the U.S. Food and Drug Administration (FDA) approval process for EPSOLAY(r) (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 EPSOLAY still needs to be conducted.

The Company continues to follow-up with the FDA on the scheduling of this inspection.