Key Takeaways
- The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted that the benefits of Seikagaku’s radicular leg pain treatment outweigh the risks.
- The committee pushed the agency to create a tailored indication mirroring the patients treated in the successful Phase III studies to minimize known and potential long-term harms.
- Advisory committee members also suggested medical providers may need specific training to administer the drug and access to resuscitation equipment to handle hypersensitivity reactions.
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...
The Anesthetic and Analgesic Drug Products Advisory Committee voted 8-4 on 10 January that the benefits of condoliase injection for radicular leg pain associated with confirmed nerve root impingement caused...
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