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NETSPOT™ Gallium Ga 68 Dotatate Kit Approved By FDA Using The GalliaPharm® Ge-68/Ga-68 Generator As The Source Of Gallium-68

June 2, 2016 – Advanced Accelerator Applications (AAA - The radiopharmaceutical company headquartered in SAINT-GENIS-POUILLY, France) have obtained approval from the US FDA for their diagnostic imaging NETSPOT™ Gallium Ga 68 dotatate kit. The kit will be used for the labeling of 68Ga-68 dotatate for injection, for the localization of somatostatin receptor positive neuroendocrine tumors in adult and pediatric patients using Positron Emission Tomography (PET). NETSPOT™ is the first kit approved by the FDA that will utilize the improved imaging enabled by the PET emitting Ga-68, which is conveniently obtained from Eckert & Ziegler Radiopharma’s GalliaPharm® Ge-68/Ga-68 generator.

This successful kit approval links the Eckert & Ziegler GalliaPharm® Ge-68/Ga-68 generator as the source of the Ga-68 in the kit’s package insert (PI).

GalliaPharm® is the only Ge-68/Ga-68 generator registered as a medicinal product in several countries of the European Union.  For the USA a Type II Drug Master File (DMF No. 28741) was filed with the FDA.

GalliaPharm® meets all the strict requirements of the relevant EU pharmacopoeia monograph including sterility over the entire one-year shelf-life and the Ge-68 breakthrough limit (< 0.001%). These are essential factors for the patient safety and enable the usage of the GalliaPharm® generator for kit labeling for its appropriate medicinal use for PET.

Download the AAA press release here: http://www.adacap.com/wp-content/uploads/2016/06/2016-06-02-PR-AAA-FDA-approves-NETspot-for-diagnosis-of-NETs-FINAL-ENG.pdf

About Eckert & Ziegler.
Eckert & Ziegler Strahlen- und Medizintechnik AG (ISIN DE0005659700), with approximately 700 employees, is one of the world’s largest providers of isotope technology for radiation therapy and nuclear medicine. 
Contributing to saving lives.

For enquiries please contact:
Eckert & Ziegler Radiopharma GmbH
Jan Schöpflin, Marketing
Robert-Rössle-Str. 10, 13125 Berlin, Germany
Tel.: +49 (0) 30 / 94 10 84-252, jan.schoepflin@dont-want-spam.ezag.de, www.ezag.de