Ortho Dermatologics bags FDA approval for Altreno lotion for acne treatment
Altreno FDA approval : Ortho Dermatologics, a division of Bausch Health Companies, has bagged approval from the US Food and Drug Administration (FDA) for Altreno lotion (tretinoin 0.05%) for the topical treatment of acne vulgaris in patients aged 9 years and older.
According to Bausch Health Companies, Altreno is the first formulation of tretinoin in a lotion. Also known as all-trans retinoic acid (ATRA), Tretinoin is used for acne treatment and also for acute promyelocytic leukemia treatment.
Bausch Health Companies said that Altreno lotion, which has been proven to be effective and generally well-tolerated, will be launched during the fourth quarter of this year.
Commenting on Altreno FDA approval, Bill Humphries – president, Ortho Dermatologics, said: “Today’s FDA approval of ALTRENO builds upon our strong acne portfolio, providing physicians and patients a trusted retinoid in a lotion formulated to enhance the user’s experience with the inclusion of moisturizing attributes of hyaluronic acid, glycerin and collagen.
“ALTRENO lotion spreads easily and is quickly absorbed into the skin allowing acne patients to easily incorporate this once-daily treatment into their skin care regimen.”
FDA approves Ortho Dermatologics Altreno lotion for acne treatment. Photo courtesy of pakize öztürk/Freeimages.com
Altreno FDA Approval
The acne lotion was assessed in two vehicle-controlled phase 3 trials in 1,640 patients for its safety and efficacy. Data from the trials showed that Altreno lotion yielded statistically significant reductions in inflammatory as well as non-inflammatory lesions in comparison to vehicle.
Joshua Zeichner – director, Cosmetic and Clinical Research in Dermatology, The Mount Sinai Hospital in New York City, commenting on Altreno FDA approval, said: “Topical retinoids are a foundational treatment for all patients with acne, but they often cause skin irritation.
“With the efficacy expected from a retinoid, plus a proven tolerability profile, ALTRENO will be an ideal choice for many of my patients.”
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