Jubilant Life Sciences Gets USFDAs sNDA Approval for Draximage DTPA

Jubilant Life Sciences Gets USFDAs sNDA Approval for Draximage DTPA

Jubilant Life Sciences Ltd, an integrated global pharmaceutical and life sciences company, on Thursday announced that Jubilant Pharma Ltd (JPL), a material wholly owned subsidiary of the company, through one of its wholly owned subsidiaries, has received a Supplemental New Drug Application (sNDA) approval from the USFDA for DRAXIMAGE DTPA powder for solution.

“Specifically, DRAXIMAGE DTPA is a kit for the preparation of Technetium Tc99m pentetate injection. Technetium Tc99m pentetate is a radioactive diagnostic agent indicated for brain imaging in adults; renal visualization, assessment of renal perfusion and estimation of glomerular filtration rate in adult and pediatric patients; and also lung ventilation imaging and evaluation of pulmonary embolism, when paired with perfusion imaging in adult and pediatric patients when administered by nebulizer for inhalation,” the company said.

According to the company, the expanded labeling incorporates a new route of administration and new indication which enhances the broad utility of DRAXIMAGE DTPA to include clinical applications to image and diagnose key functional aspects of the pulmonary system, and will allow physicians to perform lung ventilation studies for a much larger patient population suffering from compromised pulmonary function. The product is immediately available in the US market.

Commenting on the occasion, Shyam S Bhartia, Chairman, and Hari S Bhartia, Co-Chairman and Managing Director, said: “we are very pleased with the latest approval from USFDA for DRAXIMAGE DTPA. It reinforces our commitment to continued investment in innovation, research and development. Our goal is to bring value to products that enable physicians to deliver high quality diagnostics imaging studies.”

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