Trial Profile
Study of EZR-104 in patients with stage-2 Hypertension
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 27 Jan 2017
Price :
$35
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At a glance
- Drugs Valsartan (Primary)
- Indications Hypertension
- Focus Therapeutic Use
- 27 Jan 2017 New trial record
- 18 Jan 2017 According to an EZRA Innovations media release, the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for EZR-104. The NDA application was filed based on the clinical data from this and two pharmacokinetic studies. The Prescription Drug User Fee Act (PDUFA) goal date for NDA approval is September 10, 2017.