通用名称

mixed salts of a single-entity amphetamine

儿科标签批准日期

2019/9/13 0:00:00

特定指示/秒

Attention Deficit Hyperactivity Disorder (ADHD)

标签更改摘要

- Safety and effectiveness have not been established in pediatric patients ages 12 years and younger. - Mydayis has been studied for the treatment of ADHD in pediatric patients 6 to 12 years in two placebo-controlled safety and efficacy trials. - In the first trial, pediatric patients 6 to 12 years experienced higher rates of adverse reactions in some cases compared to patients 13 years and older, including higher rates of insomnia (30% versus 8%) and appetite decreased (43% versus 22%). - Amphetamine systemic exposures in pediatric patients 6 to 12 years following a single dose were higher than those observed in adults at the same dose (72-79% higher Cmax and approximately 83% higher AUC). A second trial evaluated a lower dose than those approved for pediatric patients 13 to 17 years; efficacy was not demonstrated for the lower dose. - A safe and effective dose cannot be established in pediatric patients 12 years and younger. - Information on adverse reactions, PK parameters, and clinical trials. - Postmarketing requirement.

治疗类别

CNS Stimulants

立法类型

PREA + BPCA

产品说明书链接

书号

3.0 2.0 1.0

研究年龄

4 YEARS - 12 YEARS 4 YEARS - 5 YEARS 6 YEARS - 12 YEARS

学习类型

Safety,Tolerability Safety,Pharmacokinetic,Tolerability Efficacy,Safety

研究设计

Open-Label,Phase 3,Long-term Multicenter,Open-Label,Phase 1 Randomized,Placebo,Double-Blind,Phase 3

登记的患者

141 24 88

患者分析

N/A 24 88

中心的数量

N/A 8 27

国家数量

N/A 1 1

西班牙裔拉美裔/拉丁裔总计

N/A 0 37

非西班牙裔/非拉丁裔总人数

N/A 24 50

总数#种族不明

N/A 0 1

亚裔学生总数

N/A 0 0

黑人总数

N/A 12 21

白人总数

N/A 12 58

夏威夷或太平洋岛民总数

N/A 0 0

美洲印第安人/阿拉斯加本地人总数

N/A 0 1

其他种族总计

N/A 0 8

未知种族总数

N/A 0 0

国家

N/A United States United States