Phase III studies FX2016-11 and FX2016-12 of FMX 103 for rosacea published in Journal of the American Academy of Dermatology.- Foamix Pharma
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Sol-Gel Technologies, Ltd. announced an update regarding the FDA approval process for Epsolay (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.
Menlo Therapeutics announced that the FDA has approved Zilxi (minocycline) topical foam, 1.5%, for the treatment of inflammatory lesions of rosacea in adults. Zilxi, developed as FMX103 by Menlo's wholly-owned subsidiary Foamix Pharmaceuticals Ltd. is the first minocycline product of any kind to be approved by the FDA for use in rosacea.