Boehringer Ingelheim Animal Health USA

Warning LetterClosed

Randolph Legg President and Head of Commercial Business Boehringer Ingelheim Animal Health USA 3239 Satellite Blvd Duluth , GA 30096 United StatesFEI 3003809686Issued Mar 1, 2024Center for Veterinary Medicine

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3003809686.

Violations1

Issue DateMar 1, 2024

Product TypeDrugs

StatusClosed

Closeout LetterOct 2, 2024

Letter Details

Firm: Boehringer Ingelheim Animal Health USA
Location: Randolph Legg President and Head of Commercial Business Boehringer Ingelheim Animal Health USA 3239 Satellite Blvd Duluth , GA 30096 United States
FEI Number: 3003809686
Country: United States
Issue Date: March 01, 2024
Issuing Office: Center for Veterinary Medicine
Product Type: Drugs
Status: Closed
Closeout Letter: October 02, 2024

Summary

Boehringer Ingelheim Animal Health USA distributed false and misleading promotional materials for Senvelgo (velagliflozin oral solution), a newly approved veterinary drug for cats with diabetes, that contradicted the product's boxed warning, contraindications, and approved indication regarding serious safety risks including diabetic ketoacidosis and euglycemic diabetic ketoacidosis. The promotional "Vet Detailer" on the Senvelgo website misbranded the product by misrepresenting its safety and effectiveness profile in violation of the Federal Food, Drug and Cosmetic Act sections 201(n), 301(a), 502(a), and 502(n). The FDA deemed this violation especially concerning because the misleading claims could create false impressions about the drug's safety in a novel therapeutic class with significant risk of life-threatening adverse events.

Boehringer Ingelheim Animal Health USA FDA Warning Letter, March 1, 2024