Lantheus announces FDA acceptance of its first-to-file ANDA for generic Lutathera (Lutetium Lu 177 Dotatate)
Lantheus Holdings, Inc. announced that its Abbreviated New Drug Application (ANDA) for Lutetium Lu 177 Dotatate (177Lu-PNT2003), a generic version of Lutathera (lutetium Lu 177 dotatate), has been accepted for filing by the FDA) marking a pivotal moment in the Company’s commitment to improve patient outcomes
Lutathera is indicated for the treatment of somatostatin receptor-positive gastroentero-pancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. Based on the most recent update to the FDA’s online paragraph IV database listings, 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.
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