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Jazz Fibromyalgia Candidate Needs More Risk Management, Advisory Panel Tells FDA

This article was originally published in The Pink Sheet Daily

Executive Summary

Members side with the agency against a new name and a separate Risk Evaluation and Mitigation Strategy for the new indication.

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Narrower Indication, New Studies Are Likely Riffs For Jazz Fibromyalgia Drug

Jazz Pharmaceuticals will likely have to narrow the proposed indication for its fibromyalgia drug JZP-6 (sodium oxybate) following a "complete response" letter from FDA, but that appears to be only the first step for the product.

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