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Boehringer Ingelheim Animal Health USA - 674535 - 03/01/2024

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/boehringer-ingelheim-animal-health-usa-674535-03012024

… Senvelgo (velagliflozin oral solution) CMS #: 674535 WARNING LETTER Dear Mr. Legg: The U.S. Food and Drug … misleading promotional communication contradicts the boxed warning, contraindications, and approved indication of your … insulin.” 2 Senvelgo’s FDA-approved PI contains a boxed warning due to increased risk of diabetic ketoacidosis (DKA) …

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