Download jubilant draximage receives fda approval for ruby

JUBILANT DRAXIMAGE RECEIVES FDA APPROVAL FOR RUBY-FILL®
RUBIDIUM 82 GENERATOR AND ELUTION SYSTEM
RUBY-FILL® is an approved cutting edge technology for PET myocardial perfusion imaging
(MPI) under rest and pharmacological stress conditions to evaluate regional myocardial
perfusion in adult patients with suspected or existing coronary artery disease.
MONTREAL, Quebec – October 3, 2016 - Jubilant DraxImage Inc., (“DraxImage”) a
wholly Owned Subsidiary of Jubilant Pharma Ltd, announced today that the U.S. Food
and Drug Administration has approved RUBY-FILL®, an innovative technology for
Positron Emission Tomography (PET) myocardial perfusion imaging (MPI). Comprised of
a Rubidium-82 (Rb-82) Generator and precedent setting Elution System, RUBY-FILL® is
used to produce a personalized patient dose of Rubidium Rb 82 chloride used to
evaluate regional myocardial perfusion in adult patients with suspected or existing
coronary artery disease (CAD) which is an important component of diagnosing CAD.
“We are proud to bring to the US market a groundbreaking, state-of-the-art technology
for myocardial perfusion imaging. RUBY-FILL® expands DraxImage’s nuclear medicine
portfolio and is a part of our commitment to provide healthcare providers and their
patients with innovative health care solutions for those with suspected or existing
coronary artery disease,” comments GP Singh, CEO of Jubilant Pharma Ltd.
“Our knowledge of the role and value of PET nuclear cardiology, specifically Rb- 82
Chloride PET in known or suspected coronary artery disease, advanced significantly as
we progressed through the comprehensive and rigorous FDA review process,” said
Norman LaFrance, MD, Chief Medical Officer and Senior VP, Medical & Regulatory
Affairs, for Jubilant Pharma and Jubilant DraxImage. “With its advanced weight based
dose accuracy and multiple infusion options, among other product capabilities, RUBYFILL® will enhance the way patients with known or suspected coronary artery disease are
both diagnosed and managed.”
Commercial launch plans for RUBY-FILL® is expected to be in the October-December
2016 quarter.
RUBY-FILL® Rubidium 82 Generator and RUBY Rubidium Elution System
The RUBY-FILL® Generator contains an accelerator produced Strontium-82, which decays
to Rubidium-82. When the generator is eluted with saline it produces a sterile, nonpyrogenic solution of Rb-82 Chloride.
Due to the short half-life (75 s) of Rb-82, the use of an elution system is required
for delivery of the Rb-82 Chloride into a patient for the purposes of performing
Myocardial Perfusion Imaging with PET. PET imaging with Rb-82 Chloride may be
performed under rest and/or stress conditions.
The Rubidium Elution System has been exclusively designed to be used with the RUBYFILL® generator and to deliver accurate doses of Rb-82 Chloride to patients.
For more information, please contact:
Medical & Regulatory Affairs - [email protected]
or visit http://www.draximage.com/en/pipeline/cardiovascular-pet.html
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 of Sr 82 or Sr 85 in the
rubidium Rb 82 chloride injection exceed specific limits.
 Perform generator eluate tests:
1) Determine Rb 82, Sr 82, Sr 85 levels in the eluate:
 Once daily, prior to any drug administration, and
 With additional daily tests after detection of an Alert Limit.
2) Stop use of the generator at its Expiration Limit.
About Jubilant DraxImage
Jubilant DraxImage Inc., a wholly Owned Subsidiary of Jubilant Pharma Ltd, which is held
by Jubilant Life Sciences Ltd, develops, manufactures and commercializes
radiopharmaceuticals used for the diagnosis and treatment of diseases. 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 and brain imaging) and MDP
(bone imaging), and also markets other products such as Sestamibi, Xenon and
Gluceptate. The company has a strong development pipeline of new products and
commitment in bringing new products to market. For more info: www.draximage.com
About Jubilant Life Sciences
Jubilant Life Sciences Limited is an integrated global Pharmaceutical and Life Sciences
Company engaged in Pharmaceuticals, Life Science Ingredients and Drug Discovery
Solutions. The Pharmaceuticals segment, through its wholly owned subsidiary Jubilant
Pharma Ltd, is engaged in manufacture and supply of APIs, Solid Dosage Formulations,
Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile
and Non Sterile products through 6 USFDA approved facilities in India, US and Canada.
The Life Science Ingredients segment is engaged in Specialty Intermediates, Nutritional
Products and Life Science Chemicals through 5 manufacturing facilities in India. The
Drug Discovery Solutions segment provides proprietary in-house innovation and
collaborative research and partnership for out-licensing through 3 world class research
centres in India and US. Jubilant Life Sciences Ltd has a team of around 6,500
multicultural people across the globe and is committed to deliver value to its customers
spread across over 100 countries. The Company is well recognized as a ‘Partner of
Choice’ by leading pharmaceuticals and life sciences companies globally. For more info:
www.jubl.com.