Jubilant DraxImage receives approval from Health Canada for the RUBY Elution System™ (RbES) and proprietary RUBY™ Consumable Accessories
Montreal, QC, Oct. 13, 2017 (GLOBE NEWSWIRE) -- Jubilant DraxImage Inc. (“DraxImage”), a Jubilant Pharma whollyowned subsidiary, is pleased to announce it has received approval from Health Canada for its state-ofthe-art RUBY Elution System (RbES) and the proprietary RUBY consumable accessories for use with the already approved RUBY-FILL® Rubidium-82 Generator for Positron Emission Tomography of the myocardium.
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RUBY-FILL® is a closed system used to produce a personalized patient dose of rubidium (Rb-82) chloride injection for intravenous use. Rubidium (Rb-82) chloride injection is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.
DraxImage and Jubilant Pharma Senior Vice-President of Medical & Regulatory Affairs and Chief Medical Officer, Dr. Norman LaFrance stated, “Jubilant DraxImage is extremely excited about this latest approval in Canada, which will expand access of this next-generation PET product. With its advanced weight-based dose accuracy and infusion options, RUBY-FILL® will enhance the way patients with known or suspected coronary artery disease are both diagnosed and managed in Canada.”
“This approval is another demonstration of DraxImage’s commitment to the sustainability of nuclear medicine. Our goal is to grow SPECT and PET imaging globally as part of our company’s continued mission to bring value to products that enable physicians to deliver high quality diagnostic studies,” commented Mike Rossi, Jubilant DraxImage President.
The RUBY-FILL® Generator and the RUBY Elution System provide the latest technology in PET Myocardial Imaging. The RUBY-FILL Generator and the RUBY Elution system are currently available for all Canadian customers, today, and is part of DraxImage’s larger commitment to investing in the growth and the continued advancement of nuclear medicine globally and especially in the global cardiology market. DraxImage Customer Service Contact Phone: 1-888-633-5343 or customerservice@draximage.com
For more information, please contact:
| Mr. James A. Kaufman, Vice President, Marketing | |
| Jubilant DraxImage, Inc. | |
| jkaufman@jdi.jubl.com | www.draximage.com |
About RUBY-FILL®
INDICATION: RUBY-FILL is a closed system used to produce rubidium (Rb-82) chloride injection for intravenous use. Rubidium (Rb-82) chloride injection is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.
Important Safety Information
WARNING: UNINTENDED STRONTIUM 82 (Sr 82) AND STRONTIUM 85 (Sr 85) RADIATION EXPOSURE
Please see full prescribing information for complete boxed warning
- Unintended radiation exposure occurs when the levels for Sr 82 or Sr 85 in the rubidium Rb 82 chloride injection exceed specific limits.
- Perform generator eluate tests:
- Determine Rb 82, Sr 82, Sr 85 levels in the eluate
- Once daily, prior to any drug administration, and
- With additional daily texts after detection of an Alert Limit.
2. Stop use of the generator at is Expiration Limit.
Please visit www.draximage.com for full Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
About Jubilant DraxImage
Jubilant DraxImage Inc., a subsidiary of Jubilant Life Sciences, develops, manufactures and commercializes radiopharmaceuticals used for the diagnosis and treatment of disease. The company is dedicated to nuclear medicine and serves customers and through them patients, globally, with high quality and reliable products and services. The company is the market leader in North America for I-131 products (diagnosis and treatment of thyroid disorder and cancer), MAA (lung perfusion imaging), DTPA (renal, Brain imaging) and MDP (bone imaging), and also markets other products such as Sestamibi (myocardial perfusion imaging), Gluceptate (brain and renal imaging), and Rubidium-82 Generator (PET Cardiology). The company also has a strong development pipeline of new products.
Attachments:
A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/9114adb7-80e4-4d6b-8fa4-a2a55584be98
Donna Schork Jubilant DraxImage 5146948220 donna.schork@jdi.jubl.com
