申请企业

Baxalta US Inc.

药品名称

ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated

状态

提交

承诺描述

Deferred pediatric study under PREA for routine prophylaxis to compare the efficacy and safety of two different pharmacokinetics (PK) guided dosing regimens in pediatric patients ages 12 to less than 17 years (A phase 3, prospective, randomized, multi-center clinical study comparing the safety and efficacy of ADYNOVATE following PK-guidedprophylaxis targeting two different FVIII trough levels in subjects with severeHemophilia A [clinical study 261303] - PEDIATRIC COMPONENT ONLY)

承诺状态描述

The final report was submitted to FDA on 10/4/19

报告接收日期

2021/1/11 0:00:00

批准日期

2015/11/13 0:00:00

截止日期

2019/9/30 0:00:00

CDER/CBER

CB

子类型标记

P