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We are confident that we will resolve the matters outlined in the warning letter to the FDAs full satisfaction. The FDA has issued other warnings and communications to Novo recently, including one in September 2025 for deceptive and misleading advertising linked to its semaglutide products, and an inspection report made public in August 2025 flagging violations at a manufacturing plant in Indiana.

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It also slows gastric emptying and prolongs digestion, which helps control food intake