Israel-Medical-Healthcare

[midastouch017]

Sol-Gel Technologies Announces Positive Update Related to FDA Review Status of EPSOLAY®

https://finance.yahoo.com/news/sol-gel-technologies-announces-positive-120000521.html

FDA informs Sol-Gel that it intends to conduct a pre-approval inspection of the production site for EPSOLAY during the week of February 14th, 2022

NESS ZIONA, Israel, Dec. 21, 2021 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, announced today that the Food and Drug Administration (FDA) has informed the Company that it intends to conduct a pre-approval inspection of the production site for the Company’s drug product, EPSOLAY®, a proprietary topical formulation of benzoyl peroxide, 5%, during the week of February 14th, 2022. EPSOLAY is under review by the FDA for the treatment of the inflammatory lesions of rosacea in adults.

“We are pleased that the FDA has informed us of the timing of its pre-approval inspection of the production site for EPSOLAY, which, since April 26, 2021, has been delayed due to COVID-19 related travel restrictions,” said Alon Seri Levy, Ph.D., Chief Executive Officer of Sol-Gel. “We believe that EPSOLAY has the potential to change the treatment landscape for adult patients suffering from inflammatory lesions of rosacea, a skin disorder that affects millions of people in the U.S. and expect that this development will bring us closer to the anticipated EPSOLAY approval and launch in the U.S. by our partner Galderma.”

About EPSOLAY

EPSOLAY is a topical cream containing benzoyl peroxide, 5%, under FDA review for the treatment of inflammatory lesions of rosacea in adults. EPSOLAY utilizes a proprietary technology to encapsulate benzoyl peroxide within silica-based microcapsules to create a barrier between the medication and the skin. The silica-based shell is designed to slowly release benzoyl peroxide over time to provide a favorable efficacy and safety profile. EPSOLAY is protected by granted patents until 2040.