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Sol-Gel Wins FDA Approval For Fixed-Dose Combination Of Tretinoin, Benzoyl Peroxide For Acne Vulgaris

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  • The FDA has approved Sol-Gel Technologies Ltd's (NASDAQ: SLGL) first proprietary drug product, Twyneo (tretinoin/benzoyl peroxide) cream, 0.1%/3%, indicated for acne vulgaris in adults and pediatric patients nine years of age and older.

  • Twyneo uses Sol-Gel's patented technology to entrap tretinoin, a retinoid, and benzoyl peroxide within silica-based microcapsules to stabilize tretinoin from being degraded by benzoyl peroxide and to release each of the active drug ingredients slowly.

  • The product is patent-protected until 2038.

  • Sol-Gel has partnered with Galderma to commercialize Twyneo in the U.S.

  • Sol-Gel expects to receive a regulatory milestone payment in conjunction with the approval.

  • Price Action: SLGL shares are up 2.56% at $12.42 during the market session on the last check Tuesday.

  • Related content: Benzinga's Full FDA Calendar.

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