通用名称

clascoterone

儿科标签批准日期

2020/8/27 0:00:00

特定指示/秒

Acne vulgaris in patients 12 years of age and older

标签更改摘要

- Safety and effectiveness for the topical treatment of acne vulgaris have been established in 641 pediatric patients, aged 12 to 18 years in two identical multicenter, randomized, double-blind, vehicle-controlled, 12-week trials and 2 open-label pharmacokinetic studies. - Safety and effectiveness for the topical treatment of acne vulgaris has not been established in pediatric patients under 12 years. - Hypothalamic-pituitary-adrenal (HPA) axis suppression was observed in 2/22 (9%) adolescent patients. All patients returned to normal HPA axis function at follow-up 4 weeks after stopping the treatment. Children may be more susceptible to systemic toxicity when treated with clascoterone. - Information on safety profile, PK and PD parameters, and clinical trials. - New drug.

治疗类别

Acne Agents

立法类型

PREA Only

产品说明书链接