News | January 18, 2013

GE Files Supplemental New Drug Application for Its Own Manufacturing of Optison Ultrasound Contrast

Upon approval, GE Healthcare’s Oslo facility will provide stock to the United States, becoming the only contrast media manufacturer to supply its own stock to the U.S. market

January 18, 2013 — GE Healthcare announced that it has filed a supplemental new drug application (sNDA) that will allow the company to manufacture Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), within its own facility. Optison is a contrast agent that may improve the visualization of the left ventricular border — an area of the heart that is critical to see in order to assess and diagnose certain heart diseases. Upon approval, GE Healthcare will provide supply of Optison to the U.S. market from its manufacturing facility in Oslo, becoming the only contrast media manufacturer to supply its own stock for the United States.

Optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve delineation of the left ventricular endocardial borders. Optison is not for use in patients with known or suspected: (1) Right-to-left, bi-directional, or transient right-to-left cardiac shunts, or (2) hypersensitivity to perflutren, blood, blood products or albumin. It should not be administered by intra-arterial injection. As for all ultrasound contrast agents, Optison has a boxed warning indicating that serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Healthcare professionals should assess all patients for the presence of any condition that precludes Optison administration and always have resuscitation equipment and trained personnel readily available.

Optison remains an important diagnostic option for patients with suboptimal echocardiograms. Additionally, Optison offers a unique, convenient value to clinicians and patients: It is stable at room temperature for up to 24 hours and takes less than 60 seconds to prepare, allowing for quick access to contrast in hospital settings like the cardiac lab or emergency room.

Optison vials do not contain preservative and are for single patient use only. Healthcare professionals should follow labeled instructions for product handling and use and discard unused product properly.

The most frequently reported adverse reactions following clinical trial use of Optison were headache, nausea and/or vomiting, warm sensation or flushing and dizziness. Cardiac arrests and other serious but non-fatal adverse reactions were uncommonly reported post-marketing. Most of these uncommon reactions included cardiopulmonary symptoms and signs such as cardiac or respiratory arrest, hypotension, supraventricular and ventricular arrhythmias, respiratory distress or decreased oxygenation. Reports also identified neurologic reactions (loss of consciousness or convulsions) as well as anaphylactoid reactions.

For more information:

Related Content

Ligand Establishes Program to Develop Captisol-Enabled, Next-Generation Diagnostic Imaging Contrast Agents
News | Contrast Media | January 19, 2018
Ligand Pharmaceuticals Inc. announced initiation of a program to develop contrast agents with reduced renal toxicity....
FDA Holds MIDAC Meeting on Gadolinium-Based Contrast Agents. Image by Marilyn Fornell
News | Contrast Media | September 07, 2017
The U.S. Food and Drug Administration (FDA) announced it would hold a meeting of the Medical Imaging Drugs Advisory...
European Medicines Agency Issues Update on Gadolinium Contrast Agents
News | Contrast Media | August 29, 2017
August 29, 2017 — The European Medicines Agency (EMA) issued a final opinion that recommended restricting the use of
Guerbet Announces Plans to Streamline Contrast Media Portfolio, gadolinium MRI contrast
News | Contrast Media | July 18, 2017
Guerbet recently announced that it will phase out sales throughout the world of two products: Hexabrix (meglumine and...
ACR Offers Revised Contrast Media in Imaging Manual
News | Contrast Media | July 17, 2017
The American College of Radiology (ACR) recently revised its authoritative guide for the safe and effective use of...
Bayer Arterion contrast Injector used to administer medical imaging contrast for CT scans.

Bayer Healthcare's Arterion contrast injector system.

Feature | Contrast Media | June 19, 2017 | Dave Fornell
Here are several updates in medical imaging...
PRAC, European Medicines Agency, gadolinium-based contrast agents, safety recommendations, brain MRI
News | Contrast Media | March 13, 2017
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency recently released new...
Lantheus Medical Imaging, Definity, FDA approval, label update, echocardiography, cardiac shunt contraindication
Technology | Contrast Media | February 02, 2017
Lantheus Medical Imaging Inc. announced U.S. Food and Drug Administration (FDA) approval of a label update for Definity...
CT, computed tomography, IV contrast media, acute kidney injury risk, Annals of Emergency Medicine study

A new study in Annals of Emergency Medicine finds no association between intravenous contrast media used in computed tomography (CT) and kidney damage. Roughly 80 million doses of IV contrast media are given every year. Credit: American College of Emergency Physicians

News | Contrast Media | January 30, 2017
Intravenous contrast media (typically iohexol or iodixanol) used in computed tomography (CT) does not appear to be...
GE Healthcare, Optison ultrasound contrast agent, FDA labeling change, cardiac shunts, intra-arterial injection
Technology | Contrast Media | October 04, 2016
GE Healthcare announced that the U.S. Food and Drug Administration (FDA) has approved a label change for the ultrasound...
Overlay Init