通用名称

minocycline

儿科标签批准日期

2019/10/18 0:00:00

特定指示/秒

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 pediatric patients 9 years and older for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris. - Use for this indication is supported by three adequate and well-controlled 12-week trials in patients 9 years and older. A total of 686 patients 9 years and older received Amzeeq in these clinical trials. - Safety and effectiveness for this indication have not been established in pediatric patients less than 9 years. - The use of oral tetracycline drugs during tooth development below the age of 8 years may cause permanent discoloration of the teeth and inhibition of bone growth. - Information on PK parameters and clinical trials. - New dosage form.

治疗类别

Acne Agents

立法类型

PREA Only

产品说明书链接

书号

1.0

研究年龄

10 YEARS - 16 YEARS

学习类型

Pharmacokinetic

研究设计

Traditional PK

登记的患者

20

患者分析

N/A

中心的数量

1

国家数量

1

西班牙裔拉美裔/拉丁裔总计

N/A

非西班牙裔/非拉丁裔总人数

N/A

总数#种族不明

N/A

亚裔学生总数

N/A

黑人总数

N/A

白人总数

N/A

夏威夷或太平洋岛民总数

N/A

美洲印第安人/阿拉斯加本地人总数

N/A

其他种族总计

N/A

未知种族总数

N/A

国家

N/A