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Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee


On Tuesday to Wednesday, April 24-25, 2018, the Arthritis Advisory Committee (AAC) and the Drug Safety and Risk Management (DSRM) Advisory Committee met jointly to review and provide input on safety data from the PRECISION trial, a cardiovascular outcomes trial that compared Celebrex (celecoxib) to ibuprofen and naproxen, that was submitted by Pfizer, Inc. (Pfizer) in a supplemental new drug application (sNDA). The FDA also sought input on whether the findings of the trial should change the Agency’s current understanding of the safety of three nonsteroidal anti-inflammatory drugs (NSAIDs), including interpreting drug interactions between the three drugs and aspirin in patients taking aspirin for secondary prevention of cardiovascular disease.

Earlier Event: April 23
Science Board to FDA