FDA grants priority review designation for crofelemer NDA
FDA has granted priority review designation for Salix Pharmaceuticals' NDA for crofelemer 125mg tablets for the treatment of diarrhea in patients with HIV/AIDS on anti-retroviral therapy.
Based on this review classification, the FDA has issued an action date for the NDA of 5 June 2012 under the Prescription Drug User Fee Act (PDUFA).
Salix chief development officer Bill Forbes said they believe the availability of crofelemer has the potential to change the treatment paradigm for HIV/AIDS patients suffering from diarrhea.
"This review classification signals that the FDA believes that crofelemer has the potential to provide a significant advance in the treatment of HIV/AIDS-associated diarrhea for patients on ART," Forbes added.
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