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Letter to the FDA Urging the Agency Not to Approve the New Drug Application for a Tramadol-Celecoxib Fixed-Dose Combination Product for Management of Acute Pain

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Public Citizen strongly urged the Food and Drug Administration (FDA) not to approve the new drug application submitted by Esteve Pharmaceuticals for a tramadol-celecoxib fixed-dose combination product for management of acute pain in adults because evidence from recent studies strongly counters the dangerously false assumption that tramadol, which was placed in schedule IV under the Controlled Substances Act in 2014, is safer; less likely to cause misuse, dependence, and addiction; and has a better safety profile than schedule II and schedule III opioids.

See Public Citizen’s other work on opioid drug issues.