Lantheus Announces Acceptance of its First-to-File ANDA for Generic LUTATHERA® (Lutetium Lu 177 Dotatate)

January 11, 2024

https://www.globenewswire.com/news-release/2024/01/11/2807869/0/en/Lantheus-Announces-Acceptance-of-its-First-to-File-ANDA-for-Generic-LUTATHERA-Lutetium-Lu-177-Dotatate.html

BEDFORD, Mass., Jan. 11, 2024 (GLOBE NEWSWIRE) — Lantheus Holdings, Inc. (“Lantheus” or the “Company”) (NASDAQ:LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today 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 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 (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.

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