FDA Policy/General

FDA Warns Elanco Animal Health About Pradalex Ads

The Center for Veterinary Medicine (CVM) says promotional communications for Elanco Animal Health’s Pradalex (pradofloxacin injection) contain false or misleading claims and representations about the product’s safety and effectiveness. A just-released 1/6 Warning Letter says the promotional communications misbrand Pradalex, which CVM says is especially concerning because pradofloxacin is in the fluoroquinolone drug class of drugs that are considered critically important antimicrobials in human medicine.

The letter says Pradalex is indicated to treat bovine respiratory disease associated with specific pathogens and swine respiratory disease associated with specific pathogens.

CVM raises concerns about the promotional materials’ claims that Pradalex can be used the first time an animal is treated for a specific condition (first pull) since the labeling has a Caution that the drug should only be used “after consideration of other non-fluoroquinolone therapeutic options.”

The letter also raises concerns that the ads suggest that the drug is effective against all pathogens rather than specific ones. And it raises issues with the comparative claims cited in some of the materials.

CVM tells Elanco to respond to its concerns with a list of all promotional materials for Pradalex containing the same or similar representations and a plan for either discontinuing use of the promotional materials or ceasing distribution of the drug.

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