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Seikagaku’s Pain Drug May Need More Tailored Indication, REMS For Approval

 
• By Sarah Karlin-Smith

An FDA advisory committee will consider modifications to the indicated patient population, as well as the appropriate health professionals and settings to administer the proposed treatment for radicular leg pain.

older woman cringing with lower back, leg pain
The FDA may narrow the patient population and limit treatment sites for Seikagaku's leg pain drug. (Shutterstock)

Seikagaku Corporation may need a narrower indication and a Risk Evaluation and Mitigation Strategy limiting the providers and administration of its radicular leg pain treatment to gain US Food and Drug Administration approval.

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