News | September 22, 2008

FDA Clears Covidien’s Generic Tc 99m Sestamibi Cardiac Radiotracer

September 23, 2008 – The FDA has granted approval for Covidien’s generic kit for the preparation of technetium Tc99m Sestamibi injection use for nuclear myocardial perfusion imaging.

Covidien’s product is a generic version of Cardiolite, which is a myocardial perfusion imaging agent used for detecting coronary artery disease. The branded product is utilized in nearly 60 percent of the 15 million myocardial perfusion imaging studies performed in the U.S. annually.

With FDA approval of Covidien’s abbreviated new drug application (ANDA), the generic product is now available for customers in the U.S. The company’s generic product also has recently received final regulatory approval in Denmark, Germany and the U.K.

The marketing exclusivity period for Lantheus Medical Imaging’s Cardiolite ended on July 29. The new generic product will challenge the name brand, which has been an industry standard and marketed in the U.S. for the past 17 years.

Lantheus said it will continue to market Cardiolite in the upcoming competitive generic marketplace and will stand by its existing distribution network, customer service and radiopharmaceutical manufacturing processes. Lantheus said it also plans to be competitive in its pricing.

The company said Cardiolite has been used to image more
than 40 million patients and has been the subject of more than 10,000 publications. The company said it was also the imaging agent choice in a number of seminal clinical trials, including DIAD, COURAGE, BARI-2D, ERASE, INSPIRE, IMAGING HF, STITCH and CHRISTMAS.

For more information, www.lantheus.com, www.covidien.com

Related Content

University of Missouri Research Reactor First U.S. I-131 Supplier in 30 Years

MURR is the only supplier of I 131 in the United States and the first U.S. supplier since the 1980s. Image courtesy of University of Missouri

News | Radiopharmaceuticals and Tracers | November 13, 2018
The University of Missouri Research Reactor (MURR) recently shipped its first batch of Iodine-131 (I-131), a...
MEDraysintell Projects Increasing Mergers and Acquisitions in Nuclear Medicine
News | Nuclear Imaging | November 07, 2018
With the recent announcement by Novartis to acquire Endocyte , interest from the conventional pharmaceutical industry...
CORAR Supports Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018
News | Radiopharmaceuticals and Tracers | October 12, 2018
October 12, 2018 — The Council on Radionuclides and Radiopharmaceuticals Inc.
PET Imaging Agent Predicts Brain Tau Pathology, Alzheimer's Diagnosis
News | PET Imaging | September 05, 2018
Eli Lilly and Co. and Avid Radiopharmaceuticals Inc. announced a Phase 3 study of positron emission tomography (PET)...
Abnormal Protein Concentrations Found in Brains of Military Personnel With Suspected CTE

Researchers are using the tracer, which is injected into a patient, then seen with a PET scan, to see if it is possible to diagnose chronic traumatic encephalopathy in living patients. In this image, warmer colors indicate a higher concentration of the tracer, which binds to abnormal proteins in the brain. Credit UCLA Health.

News | PET Imaging | August 24, 2018
August 24, 2018 — In a small study of
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...
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...
News | Radiopharmaceuticals and Tracers | May 09, 2018
Blue Earth Diagnostics signed an exclusive, worldwide agreement with Scintomics GmbH, Germany, a specialist in...
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...