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Jubilant DraxImage receives FDA approval for RUBY-FILL Rubidium 82 Generator and elution system

Press releases may be edited for formatting or style | October 04, 2016 Molecular Imaging

For more information, please contact:
Medical & Regulatory Affairs medicalaffairs@jdi.jubl.com
[or visit http://www.draximage.com/en/pipeline/cardiovascular-pet.html ]

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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.

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