Sol-Gel Technologies Announces FDA Approval of TWYNEO
- TWYNEO?, a once-daily cream treatment for acne vulgaris, is the first FDA-approved fixed-dose combination of tretinoin and benzoyl peroxide
- TWYNEO utilizes Sol-Gel?s proprietary microencapsulation technology and is patent protected until 2038
- Under a previously announced license,?Sol-Gel?to receive regulatory milestone payment from?U.S.?commercialization partner, Galderma, in conjunction with this approval and retains the option to regain commercialization rights five years following first commercialization?in the?U.S.
- Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with use of benzoyl peroxide products.
- Skin Irritation: Pain, dryness, exfoliation, erythema, and irritation may occur with use of TWYNEO. Avoid application of TWYNEO to cuts, abrasions, eczematous or sunburned skin.
- Photosensitivity: Minimize unprotected exposure to sunlight and sunlamps. Use sunscreen and protective clothing when sun exposure cannot be avoided.