Jubilant Life Sciences today said its wholly-owned subsidiary has received approval from the US health regulator for RUBY-FILL — Rubidium 82 generator and elution system — used in diagnosis of coronary artery disease in the US market.
In a BSE filing, the company said, “Its wholly-owned subsidiary Jubilant Pharma, through one of its units Jubilant DraxImage 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 further said: “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.”
Jubilant Life Sciences Chairman Shyam S Bhartia and Co Chairman and MD Hari S Bhartia said the medical community was looking forward to this approval, which is expected to give further boost to revenues and profitability of the company along with “the robust existing product base”.
Jubilant Life Sciences said 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.
Shares of Jubilant Life Sciences were trading 6.82 per cent higher at Rs 656.55 on BSE.