FDA grants marketing approval of NephroScan from Theragnostics
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Theragnostics announced the FDA has granted its radiodiagnostic imaging drug NephroScan for marketing approval.
According to a company press release, NephroScan is first FDA-approved drug for the company and is a “proprietary kit for the preparation of technetium Tc 99m succimer injection.” Manufactured by ROTOP Pharmaka GmbH in Germany, NephroScan was designed to aid in the evaluation of renal parenchymal disorders among adult, pediatric and neonate patients.
“The FDA approval of NephroScan is a significant milestone for Theragnostics and for patients who are affected by kidney disease,” Greg Mullen, president and CEO of Theragnostics, said in the release. “NephroScan enables the detection and diagnosis of kidney disease, enabling physicians, patients and their families to help make informed treatment decisions. The approval has been a remarkable team effort in collaboration with the regulatory development group at Facet Life Sciences and the specialists for radiopharmaceutical development and manufacturing at ROTOP Pharmaka GmbH.”
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