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Relistor Expansion Plans In Question Following “Complete Response” Letter

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA requested more clinical data on Salix/Progenics’ sNDA for approval of the subcutaneous formulation of methylnaltrexone in chronic, non-cancer pain patients with opioid-induced constipation. The regulatory setback could have implications for the companies’ planned September filing of an oral formulation in the same patient population.

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