Theragnostics Announces US FDA Approval for its Radiodiagnostic Imaging Drug NephroScan™ (Kit for the Preparation of Technetium Tc 99m Succimer Injection)
- NephroScan is now US FDA approved for the preparation of Tc-99m DMSA
- NephroScan aids in the detection of kidney cortical defects in adult and pediatric patients, including term neonates
- GE Healthcare to commence distribution in the US
- Manufactured by ROTOP Pharmaka in Germany
LONDON, UK, 22 February 2022 – Theragnostics announces that NephroScan, its radiodiagnostic imaging drug used as an aid for the evaluation of renal parenchymal disorders in adult and pediatric patients, including term neonates, has received Marketing Approval by the US Food and Drug Administration (“FDA”).
NephroScan, a proprietary kit for the preparation of technetium Tc 99m succimer injection, is Theragnostics’ first FDA approved drug. It is manufactured by ROTOP Pharmaka GmbH in Germany. GE Healthcare, a global leader in molecular imaging, serves as the exclusive distributor of the product in the United States and the product is now available for ordering.