News | October 21, 2009

FDA Reviews CorVue SPECT Pharmacologic Stress Agent

October 21, 2009 – King Pharmaceuticals Inc. said today the U.S. Food and Drug Administration issued a complete response letter regarding the new drug application (NDA) for its cardiac pharmacologic stress agent CorVue (binodenoson), and the company is working on a response.

CorVue is an injectable cardiac pharmacologic stress agent for use as an adjunct in SPECT (single-photon-emission computed tomographic) perfusion imaging. It is intended for use in patients with or at risk for coronary artery disease who are unable to perform a cardiac exercise stress test.

King is currently evaluating the FDA’s complete response letter and expects to respond to the agency’s questions as quickly as possible.

CorVue, a selective adenosine A2A receptor agonist, is being developed as an alternative to exercise prior to cardiac perfusion imaging for the diagnosis of coronary artery disease. CorVue is designed to minimize side effects such as dyspnea, flushing, heart block and chest pain. For ease of administration, CorVue is being developed for dosing as a single IV injection. CorVue has a fast onset while providing a sufficient duration of coronary blood vessel dilation for flexibility in diagnostic imaging.

For more information: www.kingpharm.com

Related Content

PET/CT Changes Care for 59 Percent of Suspected Recurrent Prostate Cancer Cases
News | Prostate Cancer | June 13, 2018
A recently presented investigational clinical trial evaluated the impact of 18F fluciclovine positron emission...
Nuclear imaging scan showing very good tissue delineation. Scan performed on a Biograph Vision positron emission tomography/computed tomography (PET-CT) system from Siemens Healthineers.

Nuclear imaging scan showing very good tissue delineation. It offers crisp overall image quality and sharply delineates the muscle and fat planes, vertebral margins and end plates, billiary radicals, renal calyces, aortic wall and papillary muscles of the heart. Scan performed on a Biograph Vision positron emission tomography/computed tomography (PET-CT) system from Siemens Healthineers.

Technology | PET-CT | June 05, 2018
June 5, 2018 — The U.S.
Emerging Trends in Nuclear Medicine
Feature | Nuclear Imaging | June 04, 2018 | By Jeff Zagoudis
Nuclear imaging and its various modalities have long played an important role in the diagnosis and treatment of numer
PET Imaging Agent Could Provide Early Diagnosis of Rheumatoid Arthritis

Coronal 18F-FEDAC PET/CT section of a mouse with collagen-induced arthritis. (A) On day 23 and day 37, increased uptake is noted in the front and hind paws of this mouse with collagen-induced arthritis. (B) Predictive performance of day 23 18F-FEDAC uptake for the development of clinical arthritis. ROC = receiver operating characteristic; Sn = sensitivity; Sp = specificity. Credit: Seoul National University and Ewha Womans University, Seoul, South Korea

News | PET Imaging | May 17, 2018
A novel positron emission tomography (PET) tracer developed by Korean researchers can visualize joint inflammation and...
PET Imaging Shows Protein Clumping May Contribute to Heart Failure Development
News | PET Imaging | May 11, 2018
A team led by Johns Hopkins University Researchers has discovered that protein clumps appear to accumulate in the...
News | Radiopharmaceuticals and Tracers | May 09, 2018
Blue Earth Diagnostics signed an exclusive, worldwide agreement with Scintomics GmbH, Germany, a specialist in...
Cardiac MRI being performed at the DeBakey Heart Hospital.

Cardiac MRI being performed at the DeBakey Heart Hospital.

Feature | Cardiac Imaging | May 03, 2018 | By Jeff Zagoudis
Magnetic resonance imaging (MRI) for cardiac assessment provides a radiation-free alternative to other commonly used...
Novel PET Agent Could Help Guide Therapy for Brain Diseases

Rat brain 11C‐Me‐NB1 PET images (0‐60 min) superimposed on an MRI template. Credit: SD Krämer et al., ETH Zurich, Zurich, Switzerland

News | PET Imaging | April 10, 2018
Researchers have developed a new imaging agent that could help guide and assess treatments for people with various...
The Chalk River nuclear reactor license has been renewed, but will be decommissioned by 2028.

The Chalk River nuclear isotope reactor license has been renewed, but will be decommissioned by 2028. The reactor supplies about 50 percent of the world's supply of Tc99m.

Feature | Nuclear Imaging | April 02, 2018 | Dave Fornell
April 2, 2018 – The Canadian Nuclear Safety Commission (CNSC) announced March 29 that it renewed Canadian Nuclear Lab
Overlay Init