Lantheus announces acceptance of its first-to-file ANDA for generic LUTATHERA

Lantheus announced that its Abbreviated New Drug Application, ANDA, for Lutetium Lu 177 Dotatate, a generic version of LUTATHERA, has been accepted for filing by the U.S. Food and Drug Administration, FDA, marking a pivotal moment in the Company’s commitment to improve patient outcomes. LUTATHERA is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors in adults. Based on the most recent update to the FDA’s online paragraph IV database listings,1 Lantheus believes it is the first applicant to have filed a substantially complete ANDA for Lutetium Lu 177 Dotatate containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act. Should its ANDA be approved by the FDA, Lantheus believes it will be eligible for 180 days of generic marketing exclusivity in the U.S.