AAA gets orphan drug status

By AuntMinnie.com staff writers

March 5, 2014 -- Advanced Accelerator Applications (AAA) has received orphan drug designation status for gallium-68 DOTATATE.

Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) granted the designation for use of the radiopharmaceutical as a diagnostic agent for managing gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

AAA said the designation should help accelerate development of the agent for the benefit of GEP-NET patients in the U.S. and Europe.

Gallium-68 DOTATATE will be prepared using AAA's patented kit, which is reconstituted in hospital radiopharmacies without the use of a radiochemistry module. The product would be available to all hospitals, even facilities that do not have a fully equipped GMP production radiopharmacy unit.


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