FDA WARNING_LETTER - Boehringer Ingelheim Animal Health USA - March 12, 2024

The FDA issued a Warning Letter to Boehringer Ingelheim regarding promotional communications for Senvelgo (velagliflozin oral solution), specifically the Vet Detailer on their website. The FDA found these communications make false or misleading claims about Senvelgo's safety and effectiveness, misbranding the product under FD&C Act sections 502(a), 502(n), 201(n), and 301(a), and 21 CFR 202.1(e)(5).

Senvelgo is indicated for "otherwise healthy cats with diabetes mellitus not previously treated with insulin." The product's FDA-approved labeling includes a boxed warning and contraindication against use in insulin-treated cats due to increased risk of fatal diabetic ketoacidosis (DKA) or euglycemic DKA (eDKA).

The Vet Detailer states Senvelgo demonstrated "excellent efficacy and safety in multiple pivotal clinical field trials featuring over 300 insulin-naive, previously insulin-treated, and otherwise healthy diabetic cats." This statement is false and misleading because, while some insulin-treated cats were enrolled in trials, safety and effectiveness were not demonstrated for them; 32% developed ketonuria, DKA, or eDKA and were removed. The approved labeling explicitly excludes this population.

Additionally, the Vet Detailer claims "fewer monitoring requirements" and "less-intensive monitoring" compared to