Verquvo

NDA 214377, held by Msd. Vericiguat.

As of Nov 13, 2026, NDA 214377 (Verquvo), held by Msd, was first approved by FDA on Jan 19, 2021, with 3 approved supplements and 0 published complete response letters.

First approved: Jan 19, 2021
Review: Priority
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

VERQUVO is indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below


Jan 21, 2026	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 19, 2021	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

3 strengths and forms


Verquvo2.5MG · tablet;oral	Vericiguat	RxReference drug
Verquvo5MG · tablet;oral	Vericiguat	RxReference drug
Verquvo10MG · tablet;oral	Vericiguat	RxReference drug

All 4 submissions, including labeling and manufacturing supplements


Jan 21, 2026	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 10, 2023	Supplement 2Labeling · Standard review	Approved	Letter Label Medication Guide
Nov 21, 2022	Supplement 1Labeling · Standard review	Approved	Label Letter
Jan 19, 2021	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 214377
Drugs@FDA: Overview at FDA
Company: MSD

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters