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news.Salix Pharmaceuticals has submitted a new drug application (NDA) for Crofelemer for the proposed treatment of HIV-associated diarrhea, to the US Food and Drug Administration (FDA).
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Salix has a license to the HIV-associated diarrhea indication for Crofelemer and the additional indications of pediatric diarrhea and acute infectious diarrhea in North America, Europe and Japan.
Salix also has a worldwide license to all other possible human indications, including irritable bowel syndrome, for Crofelemer, the company said.
The FDA has 60 days from the date of submission to conduct a filing review to determine if the application is sufficiently complete to permit a substantive review.