申请企业

Dynavax Technologies Corporation

药品名称

HEPLISAV-B, Hepatitis B Vaccine (Recombinant), Adjuvanted

状态

延迟

承诺描述

Post-Marketing Observational Study to Evaluate the Occurrence of AcuteMyocardial Infarction in Adults 18 Years of Age and Older Who ReceiveHEPLISAV-B Compared with Another Hepatitis B Vaccine.” As outlined in yoursubmission dated October 8, 2017, using a non-randomized clustered design, thestudy conducted in Kaiser Permanente Southern California, will evaluateapproximately 25,000 patients who receive HEPLISAV-B and approximately25,000 patients who receive another hepatitis B vaccine.

承诺状态描述

The Final Analysis of Unconfirmed Events Report due date has passed with no final analysis report received, however, FDA determined that there was Good Cause for the delay and agreed with a revised report submission date.

报告接收日期

2021/1/8 0:00:00

批准日期

2017/11/9 0:00:00

截止日期

2021/6/30 0:00:00

CDER/CBER

CB

子类型标记

F