Lantheus: FDA Accepts For Filing ANDA For Generic Version Of LUTATHERA

(RTTNews) - Lantheus Holdings, Inc. (LNTH) said its Abbreviated New Drug Application for Lutetium Lu 177 Dotatate or Lu-PNT2003, a generic version of LUTATHERA, has been accepted for filing by the FDA. Should the ANDA be approved by the FDA, the company believes it will be eligible for 180 days of generic marketing exclusivity in the U.S.

LUTATHERA is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors in adults. Lantheus licensed exclusive worldwide commercialization rights to 177Lu-PNT2003 from POINT Biopharma Global in December of 2022.

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