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Pharmaceuticals / Regulatory Affairs

Petition Urges FDA, DEA to Classify Tramadol as a Schedule II Controlled Substance

Nov. 22, 2019

Public Citizen has petitioned the FDA and the Drug Enforcement Administration to reclassify tramadol as a Schedule II controlled substance because of its high potential for abuse.

Tramadol’s classification as a Schedule IV drug has “generated a false perception of the drug’s safety profile,” among prescribers and patients, the group said.

Janssen’s Ultram (tramadol) was approved in 1995 to manage pain severe enough to require the drug and for which alternative treatments are inadequate. The DEA classified it as a Schedule IV controlled substance in 2014.

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