News | March 02, 2008

FDA May Clear Covidien’s Generic Myocardial Perfusion Imaging Kit

March 3, 2008 – Covidien said that it has tentative FDA clearance for its Abbreviated New Drug Application (ANDA) for its Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, a generic of Cardiolite1, 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.

Tentative FDA approval indicates that the FDA has concluded that Covidien’s generic product is safe and effective for use as recommended in the submitted labeling. Final approval of the ANDA, which was filed by the Company’s Mallinckrodt Inc. subsidiary, is subject to the expiration of the marketing exclusivity period for the branded product on July 29, 2008.

For more information: www.covidien.com

Related Content

Osprey Medical and GE Healthcare Launch Acute Kidney Injury Educational Program
News | Angiography | September 25, 2018
September 21, 2018 — Osprey Medical announced a collaboration with GE Healthcare on Osprey’s Be Kind to Kidneys campa
Gadolinium contrast agents (GBCAs) are partly retained in the brain, raising safety concerns, as seen in this MRI.

Gadolinium contrast agents (GBCAs) are partly retained in the brain, raising safety concerns, as seen in this MRI.

News | Contrast Media | September 12, 2018
In February 2018, a workshop was held at the National Institutes of Health (NIH) in Bethesda, Maryland, to explore co
Scientists Develop New MRI Tool for Cancer Diagnosis and Therapy

Researchers in the laboratory ‘Biomedical Nanomaterials’ of NUST MISIS. Image courtesy of PR Newsfoto/NUST MISIS.

News | Oncology Diagnostics | August 24, 2018
A European research group has developed a system that allows doctors to both improve the accuracy of diagnosing...
Iron Outperforms Gadolinium as MRI Contrast Agent

Scientists at Rice's Laboratory for Nanophotonics added iron chelates (blue) and fluorescent dye (red) to multi-layered gold nanomatryoshkas to create particles that can be used for disease therapy and diagnostics. The "theranostic" nanoparticles have a core of gold (left) that is covered by silica containing the diagnostic iron and dye, which is covered by an outer shell of gold. The particles are about 20 times smaller than a red blood cell, and by varying the thickness of the layers, LANP scientists can tune the nanomatryoshkas to convert light into cancer-killing heat. (Image courtesy of Luke Henderson/Rice University)

News | Contrast Media | August 22, 2018
Rice University nanoscientists have demonstrated a method for loading iron inside nanoparticles to create magnetic...
Guerbet Partners With Imalogix on Dose Optimization With Artificial Intelligence
News | Radiation Dose Management | August 14, 2018
August 14, 2018 — Guerbet LLC USA announced a commercial partnership with Imalogix, a provider of...
Videos | Contrast Media | August 03, 2018
Lawrence Tanenbaum, M.D., FACR, vice president and director of advanced imaging at RadNet, discusses the latest resea
Guerbet, IBM Watson Health Partner on Artificial Intelligence for Liver Imaging
News | Clinical Decision Support | July 10, 2018
Guerbet announced it has signed an exclusive joint development agreement with IBM Watson Health to develop an...
Imaging agent helps predict success of lung cancer therapy
News | Oncology Diagnostics | March 08, 2018
March 8, 2018 – Doctors contemplating the best therapy for...
OptiStar Elite injector
Feature | Contrast Media Injectors | March 07, 2018 | Grand View Research Inc.
The global contrast media injectors market is expected to reach $1.4 billion by 2025, growing at a compound annual...
TriHealth in Cincinnati

TriHealth in Cincinnati.

Sponsored Content | Case Study | Contrast Media Injectors | March 06, 2018
The continuing search for advantages to improve workflow has radiology departments constantly searching for new...