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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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