Curium Submits New Drug Application for Lutetium 177 Dotatate Injection
(St. Louis. – 09 July 2024) – Curium, a world leader in nuclear medicine, announced today that it has submitted its 505(b)(2) New Drug Application for Lutetium Lu 177 Dotatate Injection, which, if approved by the U.S. Food and Drug Administration (FDA), would be intended for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETS). Curium’s submission represents a major step in its strategy to become a key player in the promising nuclear medicine therapeutic field. Curium has been developing its formulation over the past several years and has ensured that its formulation avoided infringement of any Orange Book listed…
