Eckert & Ziegler to amend file for GalliaPharm PET tracer

Eckert & Ziegler Radiopharma submitted an amendment to its drug master file to the U.S. Food and Drug Administration (FDA) for its GalliaPharm PET radiotracer.

GalliaPharm is based on germanium-68 (Ge-68)/gallium-68 (Ga-68) and is mainly used in combination with tracer kits for diagnosis of neuroendocrine tumors and prostate cancer on PET scans.

The company's proprietary Ge-68/Ga-68 generator will additionally be available in sizes of up to 100 mCi with a shelf-life of 12 months or for a maximum of 700 elutions. Gallium-68 from GalliaPharm is used for the preparation of diagnostic imaging drugs in PET.