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BioPharmaceutical United States Clinical Trials

'Clean Label' For Intercept's Ocaliva In PBC Bodes Well For NASH Claim

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Executive Summary

By determining a safe dosing regimen for Child-Pugh B and C patients, FDA was able to provide a label almost completely without contraindications despite safety concerns about liver-related adverse reactions.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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