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12:00 AM
Dec 19, 2011
 |  BC Week In Review  |  Clinical News  |  Regulatory

Crofelemer regulatory update

Salix submitted an NDA to FDA for crofelemer to treat HIV-associated diarrhea. The submission comes just a month after Napo said it terminated a 2008 deal that gave Salix rights to crofelemer in North America, Japan and Europe, excluding Liechtenstein, Norway and Switzerland. At the time, Napo claimed Salix breached the deal by "unnecessarily stalling the advancement" of crofelemer. Napo said Salix failed to submit an NDA 1 year after the report of Phase III...

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