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OTC NSAIDs Need Additional Label Warnings – FDA Advisory Panel

This article was originally published in The Pink Sheet Daily

Executive Summary

Labels for over-the-counter NSAIDS need additional information about potential risks, panel members in a joint meeting of FDA’s Arthritis and Drug Safety and Risk Management advisory committees say. Data do not show naproxen has a lower CV thrombotic event risk compared to other NSAIDs, they say.

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No GRASE For Ibuprofen, No Future In OTC Internal Analgesic Monograph

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