BioCentury
ARTICLE | Company News

FDA delays crofelemer decision again

September 6, 2012 12:39 AM UTC

Salix Pharmaceuticals Ltd. (NASDAQ:SLXP) said FDA delayed a decision for the second time on an NDA for crofelemer to treat diarrhea in HIV/AIDS patients on antiretroviral therapy. Salix now expects a decision by the end of 1Q13; the PDUFA date was Wednesday. In April, FDA delayed the PDUFA date by three months. ...