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The US health regulator has provided its approval to the wholly owned subsidiary of Jubilant Life Sciences for RUBY-FILL-Rubidium 82 generator and elution system that is used in diagnosis of coronary artery disease in the US market.
The company has said in a BSE filing that “Its wholly-owned subsidiary Jubilant Pharma, through one of its units Jubilant Draxlmage Montreal Canada, has received US Food and Drug Administration approval for RUBY-FILL, for its New Drug Application (NDA) pursuant to section 505 (b)(2) filing.”
It added that “The product is expected to be launched in the current quarter (third quarter of the financial year 2017) under the company’s registered brand name RUBY-FILL for which the current estimated US market size is USD 76 million and has a potential to grow up to USD 250 million annually in the next five years.”
