FDA Policy/General

Zenrelia Promotions ‘False and Misleading’: FDA

The FDA Center for Veterinary Medicine says its review of Web sites, a brochure, and a slide deck promoting Elanco Animal Health’s Zenrelia (ilunocitinib tablets) identified false or misleading claims or representations about the drug’s safety or effectiveness. A just-released 1/28 Warning Letter says the violations, which misbrand the drug, are especially concerning from a public health perspective because they create a misleading impression about the safety and effectiveness of Zenrelia, which is a recently approved veterinary drug in the Janus Kinase inhibitor drug class.

The letter says Zenrelia is indicated to control pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

The labeling has a Boxed Warning on the risk of fatal vaccine-induced disease from modified live virus vaccines and inadequate immune response to any vaccine in dogs receiving Zenrelia. It also has adverse event, warning, precaution, and contraindication information.

The letter details information omitted from the promotional materials and misrepresented study results. Elanco was told to respond with a list of all promotional materials that contain representations like those described in the letter and a plan to discontinue such communications or cease distribution of Zenrelia.

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