Esteve’s Tramadol/Celecoxib: US FDA Cites No Major Concerns, But Also No Advantages

 
• By Sue Sutter

Agency’s briefing document for 15 January review of the fixed-dose product combining an opioid and nonsteroidal anti-inflammatory reflects application of opioid benefit/risk framework described in June draft guidance.

Metal frame for pouring concrete. The construction of the reinforced concrete frame of the building.
The FDA's review of Esteve's E-58425 reflects the new opioid benefit/risk framework. • Source: Shutterstock

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