FDA Approves Tretinoin and Benzoyl Peroxide Cream for Acne Vulgaris

The US Food and Drug Administration (FDA) approved fixed-dose combination of tretinoin and benzoyl peroxide, 0.1% and 0.3% (TWYNEO) for the treatment of acne vulgaris in adults and pediatric patients 9 years of age and older.

Face serums for acne:

The US Food and Drug Administration (FDA) approved fixed-dose combination of tretinoin and benzoyl peroxide, 0.1% and 0.3% (TWYNEO) for the treatment of acne vulgaris in adults and pediatric patients 9 years of age and older.

This approval was granted to Sol-Gel Technologies.

The once-daily cream utilizes patented technology that entraps both tretinoin and benzoyl peroxide within silica-based microcapsules. Therefore, tretinoin is stabilized and prevented from being degraded by benzoyl peroxide.

“TWYNEO combines, for the first time, two of the most commonly used topical agents available for the treatment of acne into a single application,” said Hilary Baldwin, MD, Clinical Associate Professor of Dermatology, of Rutgers Robert Wood Johnson School of Medicin, in a statement.

“Due to stability issues, these products don’t play well together, and we were never able to recommend even consecutive co-application of the two agents. Sol-Gel’s technology has solved this problem.”

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