FDA Policy/General

‘False or Misleading’ Senvelgo Claims: CVM

The Center for Veterinary Medicine (CVM) says promotional communications for Boehringer Ingelheim Animal Health USA’s Senvelgo (velagliflozin oral solution) make false or misleading claims and representations about the drug’s safety and effectiveness. A 3/1 Warning Letter says the violations are especially concerning from a public health perspective because the misleading communications contradict the Boxed Warning, Contraindications, and Approved Indication on the product’s labeling.

Senvelgo is indicated to improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin. Its labeling contains a Boxed Warning for an increased risk of diabetic ketoacidosis or glycemic diabetic ketoacidosis, either of which may result in death.

The letter says the promotional materials contain a statement that Senvelgo “demonstrated excellent efficacy and safety in multiple pivotal clinical field trials featuring over 300 insulin-naïve, previously insulin-treated, and otherwise healthy diabetic cats.” CVM says the statement is in direct conflict with the drug’s labeling and the results from the underlying trials.

The company was told to respond by addressing the concerns raised in the letter and listing all Senvelgo promotional communications that contain similar representations, with a plan for discontinuing the use of such communications or ceasing Senvelgo distribution.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome