We believe that the use of NETSPOT should also offer increased comfort for patients by potentially shortening a procedure that is currently performed over 24 hours or more to just a few hours. “NETSPOT has the potential to significantly improve the accuracy of NET diagnosis, while reducing radiation exposure for patients. “The FDA approval of NETSPOT is a key milestone in our mission of improving the lives of NET patients,” said Stefano Buono, Chief Executive Officer of AAA. This radioactive probe will help locate tumors in adult and pediatric patients with the rare condition, somatostatin receptor positive neuroendocrine tumors (NETs).
#Netspot aaa generator#
NETSPOT is currently approved for use with the GalliaPharm Ga 68 generator from Eckert & Ziegler. AAA intends to commercialize the product in the US in two forms: As a kit for reconstitution using a Ga 68 generator, and as NETSPOT Injection, a ready-to-use dose delivered from a local radiopharmacy in selected metropolitan areas. Gallium Ga 68 dotatate received Orphan Drug Designation from both the FDA and European Medicines Agency (EMA) in March 2014.įollowing today’s approval, NETSPOT will be made available to the US market as soon as possible. NETSPOT is the first approved drug using Ga 68 as a positron emitter. aaa today announced the first administration of netspot, a product recently approved by the u.s. European Commission has approved SomaKit TOC (AAA), a kit for radiopharmaceutical preparation of gallium ( 68 Ga) edotreotide solution. NETSPOT is the new market name for Somakit-TATE (a kit for the preparation of gallium Ga 68 dotatate injection) in the US. AAA’s NETSPOT Gallium Ga 68 dotatate kit approval in the USA links GalliaPharm as the source of the 68 Ga. NETSPOT received approval following a Priority Review from the FDA. We believe that the use of NETSPOT should also offer increased comfort for patients by potentially shortening a procedure that is currently performed over 24 hours or more to just a few hours.AAA today announced that the US Food and Drug Administration (FDA) has approved NETSPOT(TM) (Somakit-TATE) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
“The FDA approval of NETSPOT is a key milestone in our mission of improving the lives of NET patients,” said Stefano Buono, Chief Executive Officer of AAA. AAA intends to commercialize the product in the US in two forms: As a kit for reconstitution using a Ga 68 generator, and as NETSPOT Injection, a ready-to-use dose delivered from a local radiopharmacy in selected metropolitan areas. AAA’s NETSPOT ® Gallium Ga 68 dotatate kit approval in the USA links GalliaPharm ® as the source of the 68 Ga. NETSPOT is the first approved drug using Ga 68 as a positron emitter. NETSPOT is the new market name for Somakit-TATE (a kit for the preparation of gallium Ga 68 dotatate injection) in the US. The group operates in all three segments of nuclear medicine (PET, SPECT and therapy) to diagnose and treat serious conditions in the fields of oncology, neurology, cardiology, infectious and inflammatory diseases. AAA today announced that the US Food and Drug Administration (FDA) has approved NETSPOT(TM) (Somakit-TATE) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. Advanced Accelerator Applications (AAA or Adacap) is a France-based pharmaceutical group, specialized in the field of nuclear medicine.
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