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Salix finally submits crofelemer NDA, but Napo disputes authority after deal end

This article was originally published in Scrip

Executive Summary

Salix Pharmaceuticals held to its word to deliver a new drug application (NDA) to the US FDA for crofelemer as a treatment for HIV-associated diarrhea, but Napo Pharmaceuticals, which terminated its deal with the company, is arguing that its former partner does not have the legal authority to submit or pursue the NDA.

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