Raleigh-based Salix Pharmaceuticals announced today that is has submitted a new drug application to the Food and Drug Administration for Crofelemer, a drug used to treat chronic diarrhea in HIV/AIDS patients.
Salix has an agreement to develop Crofelemer with San Francisco-based Napo Pharmaceuticals. Napo, which sued Salix earlier this year claiming it breached their collaboration agreement, announced last month that it had terminated the agreement.
Salix calls the lawsuit baseless and says Napo's termination of the license is groundless and without merit.
The FDA now has 60 days to conduct a filing review to determine if Salix's application is complete enough to warrant a more substantive review of Crofelemer.