US FDA warns Shionogi for misleading Cedax promotion
This article was originally published in Scrip
Executive Summary
Two professional direct mail promotions for ShionogiUSA's cephalosporin antibiotic Cedax (ceftibuten) are misleading because they minimise the product's risks and broaden its indications, the US FDAhas said in a warning letter. The mailers fail to reflect a bolded warning on hypersensitivity reactions and other labelled risks. They misleadingly imply that Cedax is effective for treating any middle ear or bronchial infection, when it is only approved for mild to moderate infections. The promotions also do not disclose that Cedax is approved for use only against susceptible strains of designated micro-organisms, therefore suggesting the antibiotic is effective against a wider range of pathogens than has been demonstrated. The FDA requests Shionogi to cease use of these and similar promotions and submit a corrective messaging plan.
You may also be interested in...
Rare Diseases: CBER Looks To ‘Lean Into’ Accelerated Approval, Align More With CDER
US FDA biologics center officials spoke about their efforts to increase collaboration and harmonization with the drugs center, and to internally involve more review disciplines in evaluating biomarker evidence, during a Reagan-Udall Foundation meeting that weighed potential use of accelerated approval for neuronopathic mucopolysaccharidoses disorders.
RWE: Non-Interventional Studies Must Be Able To Distinguish A True Treatment Effect, US FDA Says
Agency describes a host of issues sponsors should consider and address before pursuing observational or case-control studies to support regulatory decision-making on drug efficacy or safety; new draft guidance was issued under the FDA’s Real-World Evidence program.
Eye On ODAC: Former Members, FDA’s Pazdur Talk Pre-Meeting Mindsets, Impact Of Sponsor’s Experts
Oncologic Drugs Advisory Committee reps and the Oncology Center of Excellence director go behind the scenes to discuss FDA interactions with panelists, how opinions can change during a meeting, and why the voting question is important.