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.