Lantheus Announces Acceptance Of Its First-to-file ANDA With FDA For Generic Lutathera (Lutetium Lu 177 Dotatate), Indicated For Somatostatin Receptor-positive Gastroenteropancreatic Neuroendocrine Tumors
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Lantheus Holdings, Inc. has announced that the FDA has accepted its first-to-file Abbreviated New Drug Application (ANDA) for a generic version of Lutathera, which is used to treat somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. This acceptance could potentially allow Lantheus to enter the market with its generic product upon patent expiration, subject to FDA approval.
January 11, 2024 | 1:02 pm
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Lantheus Holdings, Inc.'s ANDA acceptance by the FDA for a generic Lutathera positions the company to potentially capture market share in the treatment of gastroenteropancreatic neuroendocrine tumors once the original drug's patent expires.
The acceptance of the ANDA by the FDA is a positive regulatory milestone for Lantheus, indicating progress towards bringing a generic version of Lutathera to market. This could lead to increased revenue streams for Lantheus in the future, assuming successful approval and market entry. Investors may view this news as a positive development, potentially leading to a short-term increase in the stock price.
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