NETSPOT ™ Gallium Ga 68 Dotatate Kit Approved By FDA Using The GalliaPharm® Ge-68/Ga-68 Generator As The Source Of Gallium-68
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 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® 68Ge/68Ga generator.
This successful kit approval links the Eckert & Ziegler GalliaPharm® 68Ge/68Ga generator as the source of the 68Ga in the kit’s package insert (PI).
GalliaPharm® is the only 68Ge/68Ga 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 68Ge 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 .
Note: The press release has been copied from www.ezag.com .