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Investing News NetworkOctober 20, 2023First and only FDA-approved fixed-dose, triple-combination topical treatmentBausch Health Companies Inc. (NYSE:BHC) (TSX:BHC) ('Bausch Health') and its dermatology business, Ortho Dermatologics, 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.
投资新闻网络2023年10月20日第一个也是唯一一个FDA批准的固定剂量,三联合局部治疗Bausch Health Companys Inc.(NYSE:BHC)(TSX:BHC)('Bausch Health')及其皮肤科业务,Ortho Dermatologics,今天宣布,美国食品和药物管理局(FDA)已批准新药申请CABTREOTM(磷酸克林霉素,阿达帕林和过氧化苯甲酰)局部凝胶1.2%0.15%3.1%,适用于12岁以上患者的寻常痤疮局部治疗。
CABTREO is the first and only FDA-approved fixed-dose, triple-combination topical treatment for acne. CABTREO is expected to be available to patients in Q1 2024'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.
CABTREO是第一个也是唯一一个FDA批准的痤疮固定剂量,三联组合局部治疗。预计CABTREO将在2024 Q1期提供给患者。“今天CABTREO的批准,每年有数百万患有痤疮的美国人接受新的三联局部痤疮治疗,”Thomas J.说。
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.
Appio,Bausch Health首席执行官痤疮治疗通常需要使用多种产品和给药方案,这可能对患者构成许多挑战。CABTREO有可能通过每日一次的局部痤疮治疗方案简化剂量CABTREO提供三种作用机制,结合抗生素,类维生素a和抗菌药物,提供经过验证,安全有效的治疗方法尽管目前可用的大多数痤疮治疗都采用多种疗法和方案,但我们很高兴地看到,CABTREO中的三联疗法已导致显着的治疗成功并减少了通常与痤疮相关的炎症和非炎症性病变,“朱莉C.说。
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.'CABT.
哈珀,医学博士,伯明翰皮肤科和皮肤护理中心,伯明翰,AL。“经CABTREO批准,医生现在可以为患者提供痤疮治疗,这有可能是一个简单的,每日一次的剂量选择。”CABT。