FDA Approves CabtreoTM (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel For The Treatment Of Acne Vulgaris In Patients Twelve Years Of Age And Older

發(fā)布時間： 2023-10-27 閱讀：632次

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October 20, 2023 -- Bausch Health Companies Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for CABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, indicated for the topical treatment of acne vulgaris in patients twelve years of age and older. CABTREO is the first and only FDA-approved fixed-dose, triple-combination topical treatment for acne.

“With today’s approval of CABTREO, millions of Americans who suffer from acne each year have a new triple-combination topical acne treatment,” said Thomas J. Appio, Chief Executive Officer, Bausch Health. “Acne treatment often requires using multiple products and dosing regimens, which can pose a number of challenges for patients. CABTREO has the potential to simplify dosing with a once daily topical acne treatment regimen.”

CABTREO offers three mechanisms of action, combining an antibiotic, retinoid and antibacterial, to provide a proven, safe and effective treatment.

“While most acne treatments currently available utilize multiple therapies and regimens, we are excited to see that the triple combination in CABTREO has resulted in significant treatment success and reduction in both the inflammatory and noninflammatory lesions typically associated with acne,” said Julie C. Harper, MD., Dermatology & Skin Care Center of Birmingham, Birmingham, AL. “With the approval of CABTREO, physicians can now offer patients an acne treatment that has the potential to be a simple, once daily dosing option.”