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Lantheus says FDA issues CRL for LNTH-2501 over third-party manufacturing conditions

PUBT·06/26/2026 20:01:13
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Lantheus says FDA issues CRL for LNTH-2501 over third-party manufacturing conditions
  • Lantheus received an FDA complete response letter for its NDA for LNTH-2501 (Ga 68 edotreotide), blocking approval by the June 29, 2026 PDUFA date.
  • FDA cited unresolved manufacturing conditions at a third-party drug product facility, requiring satisfactory resolution of inspection-related items before approval.
  • The letter raised no issues with the application’s clinical data, safety, or efficacy.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Lantheus Holdings Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202606261601PRIMZONEFULLFEED9753399) on June 26, 2026, and is solely responsible for the information contained therein.