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Seikagaku’s Pain Drug Gets Advisory Panel OK, But With Limited Indication

 
• By Sarah Karlin-Smith

The injection for radicular leg pain appears likely to be approved, but with a very prescriptive label to help balance safety concerns and a lack of long-term outcomes data.

Man sitting on couch wincing in pain, holding his leg.
Patients with radicular leg pain could have a new treatment option following a positive advisory committee recommendation for Seikagku's condoliase. (Shutterstock)

Seikagaku Corporations’s radicular leg pain treatment should be approved as long as the drug label is narrower than currently proposed and includes tight safety controls, a US Food and Drug Administration advisory panel said.

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Recent And Upcoming FDA Advisory Committee Meetings

 
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