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