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IBA Molecular Announces Submittal of ANDA for Ammonia N 13 Injection


2/15/2013 10:32:24 AM

Dulles, Virginia, February 11, 2013 – IBA Molecular North America, Inc. (IBA Molecular) has announced that an abbreviated new drug application (ANDA) has been submitted to and received by the U.S. Food and Drug Administration (FDA) for the radiopharmaceutical Ammonia N 13 Injection. The submission of this ANDA marks an important step in the expansion of IBA Molecular’s U.S. commercial pipeline.

Ammonia N 13 Injection is employed in PET or PET/CT scans performed for noninvasive myocardial perfusion imaging for the diagnosis and management of patients with known or suspected coronary artery disease.

“IBA Molecular is committed to supporting PET imaging programs and broadening the application of molecular imaging in key areas of patient care,” said Lee Karras, President of IBA Molecular North America, Inc. “The submittal of this ANDA is part of our continuing efforts to support our customers with products and services to better serve their patients.”

IBA Molecular expects that the product will be available at specific locations by the beginning of March 2013.

About Ammonia N 13 Injection

Ammonia N 13 Injection is a positron emitting radiopharmaceutical used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. It is administered by intravenous injection and has a physical half-life of 9.96 minutes. After administration it is distributed to all organs of the body, enters the myocardium through the coronary arteries, and is extracted from the blood into the myocardial cells; here it is metabolized to glutamine 13N and retained in the cells. The presence of Ammonia N 13 and glutamine N 13 in the myocardium allows for PET imaging of the myocardium, which is able to measure myocardial blood flow. Ammonia N 13 Injection is indicated for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease. In a key, prospective, blinded image interpretation study PET imaging using Ammonia N 13 Injection showed a sensitivity of 98% and a specificity of 85% in identifying myocardial abnormalities in patients presenting for coronary angiography. Ammonia N 13 Injection is covered by the Centers for Medicare & Medicaid Services (CMS) for the evaluation of myocardial perfusion.

About IBA Molecular

IBA Molecular North America, Inc. is a part of IBA Molecular, a global developer, manufacturer and distributor of radiopharmaceutical products and supporting services used in molecular imaging. IBA Molecular has engineered a strong and unique product portfolio and pipeline of diagnostic tracers aimed at advancing the global movement towards personalized medicine and making molecular imaging a major discipline in healthcare. Founded in 1986, IBA Molecular is jointly owned by SK Capital Partners and IBA (Ion Beam Applications S.A.), with North American headquarters in Dulles, Virginia. The company is a leading manufacturer and distributor of PET agents in North America, and PET and SPECT agents in Europe and Asia, with a network of 57 sites worldwide.

For more information, please visit http://www.ibamolecular.com.

Contact:

Colleen L. Ruby

Vice President of Key Accounts & Marketing

IBA Molecular North America, Inc.

E-mail: colleen.ruby@ibamolecular.com



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