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Xarelto Ad’s Benefit Claims Need Renal Caveats, FDA Says

 
• By Cathy Dombrowski

Typography and graphics which highlight benefits but not risks makes a print ad for Xarelto to treat atrial fibrillation misleading, FDA tells Johnson & Johnson in an untitled letter.

A blanket statement of benefit for a drug is misleading if the benefit does not apply to all patient subgroups, FDA says in an untitled letter to Johnson & Johnson about a direct-to-consumer ad for Xarelto (rivaroxaban).

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More from United States

New Guidance Suggests SubQ Keytruda, Opdivo Formulations May Not Avoid Medicare Negotiations

 
• By Sarah Karlin-Smith

New draft guidance on the third cycle of Medicare drug price negotiations goes against Merck and Keytruda’s expectations for their cancer drugs. The guidance also tackles Part B and renegotiated prices for the first time.

Mayne’s Nextstellis Promo Wrong To Suggest Better Safety Than Other Contraceptives, FDA Says

 
• By Sue Sutter

A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.

US HHS Deputy Nominee Talks AI, Not FDA, In Confirmation Hearing

 
• By Ramsey Baghdadi

Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.

US FDA Waiting On Guidance Agenda Future As HHS Seeks Regulation Cuts

 
• By Derrick Gingery

The FDA continues to wait for a decision on whether its priority guidances will be published as HHS asks the public for potential regulation cuts to fulfill President Trump’s executive order.

More from North America

US FDA Rare Disease Case Studies Provide Development Models For Sponsors

 
• By Laura Helbling

Sanofi’s Xenpozyme and Sentynyl’s Nulibry are the first two case studies the FDA is using to continue educating rare disease sponsors on best practices.

House Budget Bill Includes Delayed Orphan Fix, Also Risks Downstream Cell and Gene Coverage

 
• By Sarah Karlin-Smith

The first two classes of negotiated drugs under the Inflation Reduction Act would not benefit from a rare disease adjustment House Republicans included in their reconciliation package.

Trump’s Rx Pricing Order: The Best-Case And Worst-Case Scenarios

 
• By Derrick Gingery

US trade and tariff leverage might successfully push European and other countries to pay more for medicines, but if not, President Trump’s executive order includes potential US drug withdrawal and other options to entice industry to lower US prices.