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