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Jubilant receives sNDA approval for new indications from USFDA for DRAXIMAGE


Jubilant receives sNDA approval for new indications from USFDA for DRAXIMAGE

Noida: Jubilant Pharma Limited, a material wholly owned subsidiary of Jubilant Life Sciences Ltd, through one of its wholly-owned subsidiaries, has received a Supplemental New Drug Application (sNDA) approval from USFDA for DRAXIMAGE® DTPA (Kit for the Preparation of Technetium Tc99m Pentetate Injection) 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:

  1. Brain imaging in adults
  2. Renal visualization, assessment of renal perfusion and estimation of glomerular filtration rate in adult and pediatric patients
  3. 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 expanded labelling 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 the compromised pulmonary function. The product is immediately available in the US market.

Commenting on the occasion, Mr Shyam S Bhartia, Chairman & Managing Director, and Mr Hari S Bhartia, the Director, said: “We are very pleased with the latest approval from US FDA 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”



Source: Press Release
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