Lantheus Receives FDA Tentative Approval for Lutetium Lu 177 Dotatate
Lantheus Holdings announced that it has received U.S. Food and Drug Administration, FDA, tentative approval for the Abbreviated New Drug Application, ANDA, for Lutetium Lu 177 Dotatate, a radioequivalent version of Lutathera. Lutathera is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors.
