Celebrex Gets Committee Nod For Juvenile Arthritis, But Safety Registry Urged
Concerns about cardiovascular risks associated with COX-2 inhibitors continue to haunt Pfizer's Celebrex as FDA's Arthritis Advisory Committee asked for long-term safety data as a condition of celecoxib's approval for a pediatric indication
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The European Medicines Agency issues a formal review, even though the claim had been withdrawn, in order to discourage off-label use.
FDA Office of Drug Safety Associate Director for Science & Medicine David Graham's controversial presentation of unpublished studies on the safety of COX-2 inhibitors ultimately benefited certain COX-2s and raised questions about others in the class during a joint FDA advisory committee review
Following Merck's decision to withdraw Vioxx from the market, an FDA approval of the follow-on COX-2 inhibitor Arcoxia is likely to be delayed