Iomervu

NDA 216016, held by Bracco. Iomeprol.

As of Nov 13, 2026, NDA 216016 (Iomervu), held by Bracco, was first approved by FDA on Nov 27, 2024, with 0 approved supplements and 0 published complete response letters.

First approved: Nov 27, 2024
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

IOMERVU is a radiographic contrast agent indicated for: Intra-arterial Procedures † Cerebral arteriography, includingintra-arterial digital subtraction angiography (IA-DSA), in adults and pediatric patients Visceral and peripheral arteriography and aortography, including IA-DSA, in adults and pediatric patients Coronary arteriography and cardiac ventriculography in adults Radiographic evaluation of cardiac chambers and related arteries in pediatric patients Intravenous Procedures † Computed tomography (CT) of the head and body in adults and pediatric patients CT angiography of intracranial, visceral, and lower extremity arteries in adults and pediatric patients Coronary CT angiography in adu…

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Nov 27, 2024	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Products

13 strengths and forms

Product	Active ingredient	Marketing
Iomervu25GM IODINE/100ML (250MG IODINE/ML) · solution;intra-arterial	Iomeprol	DiscontinuedReference drug
Iomervu15GM IODINE/50ML (300MG IODINE/ML) · solution;intra-arterial	Iomeprol	DiscontinuedReference drug
Iomervu30GM IODINE/100ML (300MG IODINE/ML) · solution;intra-arterial	Iomeprol	DiscontinuedReference drug
Iomervu45GM IODINE/150ML (300MG IODINE/ML) · solution;intra-arterial	Iomeprol	DiscontinuedReference drug
Iomervu60GM IODINE/200ML (300MG IODINE/ML) · solution;intra-arterial	Iomeprol	DiscontinuedReference drug
Iomervu17.5GM IODINE/50ML (350MG IODINE/ML) · solution;intra-arterial	Iomeprol	DiscontinuedReference drug
Iomervu35GM IODINE/100ML (350MG IODINE/ML) · solution;intra-arterial	Iomeprol	RxReference drug
Iomervu52.5GM IODINE/150ML (350MG IODINE/ML · solution;intra-arterial	Iomeprol	DiscontinuedReference drug
Iomervu70GM IODINE/200ML (350MG IODINE/ML) · solution;intra-arterial	Iomeprol	RxReference drug
Iomervu20GM IODINE/50ML (400MG IODINE/ML) · solution;intra-arterial	Iomeprol	DiscontinuedReference drug
Iomervu40GM IODINE/100ML (400MG IODINE/ML) · solution;intra-arterial	Iomeprol	RxReference drug
Iomervu60GM IODINE/150ML (400MG IODINE/ML) · solution;intra-arterial	Iomeprol	DiscontinuedReference drug
Iomervu80GM IODINE/200ML (400MG IODINE/ML) · solution;intra-arterial	Iomeprol	RxReference drug

Identifiers

Application: NDA 216016
Drugs@FDA: Overview at FDA
Company: Bracco

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