Jubilant Life Sciences' arm receives USFDA approval for RUBY-FILL

03 Oct 2016 Evaluate

Jubilant Life Sciences’ wholly own subsidiary Jubilant Pharma, through one of its units Jubilant DraxImage Inc. Montreal Canada, has received US Food and Drug Administration (USFDA) approval for RUBY-FILL, for its New Drug Application (NDA). RUBY-FILL is a cutting-edge technology for PET MPI for diagnosis of coronary artery disease.

This approved new drug application provides for the use of RUBY-FILL 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.

The product is expected to be launched in the current quarter (third quarter of financial year 2017) under the company’s registered brand name RUBY-FILL for which the current estimated US market size is $76 million and has a potential to grow up to $250 million annually in the next five years.

Jubilant Life Sciences is an integrated global Pharmaceutical and Life Sciences Company engaged in manufacture and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Life Science Ingredients.

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