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:
- Brain imaging in adults
- Renal visualization, assessment of renal perfusion and estimation of glomerular filtration rate in adult and pediatric patients
- 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”