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Zegerid OTC, Private Label Omeprazole Add Drug Interaction Warnings

 
• By Malcolm Spicer

CDER approves sNDAs from Bayer for Zegerid OTC powder and private label manufacturer Dexcel Pharma for omeprazole delayed release tablets to add label warnings on drug-drug interactions for methotrexate and mycophenolate mofetil.

Labels for Zegerid OTC and a generic nonprescription proton pump inhibitor also containing omeprazole are updated with warnings that FDA, in response to a Public Citizen request, said should be added to all PPIs.

The agency’s Center for Drug Evaluation and Research in June 11 letters to Bayer HealthCare LLC for

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EU 15% Tariff Deal Still Leaves Questions For Pharma On Possible Grace Period, Generic Exemption

 
• By Jessica Merrill

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Medicare Part B ASP Proposal Sets ‘Guardrails’ Around Bona Fide Service Fee Reporting

 
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Average sales prices, and Medicare spending on some drugs, would be expected to be lower, CMS says in the Physician Fee Schedule proposed rule.

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Real-Time Release Of CRLs Is US FDA’s Goal, Agency Leaders Affirm

 
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The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.

More from North America

No Surprise Here: Foreign Drug Facilities Should Expect Surprise Inspections, US FDA Says

 
• By Sue Sutter

The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.

Base Benefit-Risk Decisions On Data, Not Opinion And Passion, CDER’s Tidmarsh Says

 
• By Sue Sutter

New US FDA drugs center director George Tidmarsh’s data-centric comments at a Reagan-Udall Foundation meeting on unapproved fluoride products could suggest patients’ and caregivers’ experiences will carry less weight in benefit-risk decisions under his leadership.

Pink Sheet Podcast: FDA’s New Top Drug Regulator, Sarepta’s Options After Elevidys Stand-Off

 
• By Derrick Gingery, Sarah Karlin-Smith, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the potential impact George Tidmarsh could have as director of the US FDA Center for Drug Evaluation and Research and the issues threatening the future of Sarepta’s gene therapy Elevidys.