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FDA advisory committees back cardiovascular safety data for Pfizer's Celebrex

Apr. 25, 2018 10:31 AM ETPfizer Inc. (PFE) StockPFEBy: Douglas W. House, SA News Editor5 Comments
  • The FDA's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee have voted 15 - 5 (1 abstain) in favor that the results from the large-scale Phase 4 PRECISION study demonstrated comparable cardiovascular safety of Pfizer's (PFE -0.8%) arthritis med CELEBREX (celecoxib) to naproxen (Aleve) and ibuprofen (Motrin).
  • If formerly approved by the FDA, which seems likely, the data will be added to the labeling of CELEBREX.

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