SLGL - Sol-Gel says no FDA notification regarding its marketing application for EPSOLAY

Sol-Gel Technologies ([[SLGL]] -21.1%) has shed more than a fifth in value after announcing that the company received no notification from the FDA regarding its marketing application for EPSOLAY (benzoyl peroxide) 5% topical cream for adults with Inflammatory lesions of rosacea.However, Sol-Gel says it received an email confirmation from the regulator which cited the need to conclude a pre-approval inspection of the production site of EPSOLAY as the reason for its inaction.Despite the pandemic-related delay on 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,” the company added.The FDA set a PDUFA date of April 26, 2021, for its marketing application for EPSOLAY, Sol-Gel announced in September 2020.

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Sol-Gel says no FDA notification regarding its marketing application for EPSOLAY