Zegerid OTC, Private Label Omeprazole Add Drug Interaction Warnings

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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