通用名称

sarecycline

儿科标签批准日期

2018/10/1 0:00:00

特定指示/秒

Treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older

标签更改摘要

- Safety and effectiveness have been established in adult and pediatric patients 9 years and older in two 12-week multicenter, randomized, double-blind, placebo-controlled studies in a total of 2002 patients. - Safety and effectiveness in pediatric patients below the age of 9 years has not been established. - Use of tetracycline-class antibiotics below the age of 8 is not recommended due to the potential for tooth discoloration. - Information on Pk parameters, and clinical trials in adults and pediatric patients 9 and older. - New drug.

治疗类别

Acne Agents

立法类型

PREA Only

产品说明书链接

书号

4.0 3.0 2.0 1.0

研究年龄

12 YEARS - 17 YEARS 9 YEARS - 17 YEARS 9 YEARS - 17 YEARS 10 YEARS - 17 YEARS

学习类型

Efficacy,Safety Safety Efficacy,Safety Efficacy,Safety

研究设计

Placebo,Single-Blind Open-Label Placebo,Single-Blind,Parallel Group Placebo,Single-Blind,Parallel Group

登记的患者

134 295 552 486

患者分析

N/A N/A N/A N/A

中心的数量

38 52 54 56

国家数量

1 1 1 1

西班牙裔拉美裔/拉丁裔总计

N/A N/A N/A N/A

非西班牙裔/非拉丁裔总人数

N/A N/A N/A N/A

总数#种族不明

N/A N/A N/A N/A

亚裔学生总数

N/A N/A N/A N/A

黑人总数

N/A N/A N/A N/A

白人总数

N/A N/A N/A N/A

夏威夷或太平洋岛民总数

N/A N/A N/A N/A

美洲印第安人/阿拉斯加本地人总数

N/A N/A N/A N/A

其他种族总计

N/A N/A N/A N/A

未知种族总数

N/A N/A N/A N/A

国家

N/A N/A N/A N/A