FDA Grants Lantheus Final Approval for Bravnetsa, Generic Equivalent to Novartis' Lutathera

Lantheus Holdings Inc. (LNTH) said Tuesday the U.S. Food and Drug Administration granted final approval for Bravnetsa, a radiopharmaceutical deemed bioequivalent and therapeutically equivalent to Novartis' Lutathera for neuroendocrine tumors. The approval positions Bravnetsa as a direct competitor to Lutathera, Novartis' established therapy for gastroenteropancreatic neuroendocrine tumors. Lantheus, which focuses on radiopharmaceuticals, did not disclose pricing or a launch timeline in the announcement dated September 22, 2026. The FDA's final designation confirms Bravnetsa meets the agency's standards for substitution at the pharmacy level, a status that typically accelerates adoption of lower-cost alternatives. Shares of Lantheus traded on the Nasdaq under the ticker LNTH.