FDA accepts Actavis NDA for eluxadoline

Ireland-headquartered generic drug major Actavis (NYSE: ACT) says that the US Food and Drug Administration has accepted for filing Actavis' New Drug Application for eluxadoline.

This is an investigational drug for the treatment of diarrhea and abdominal pain in men and women with diarrhea predominant irritable bowel syndrome (IBS-D). Actavis' NDA for eluxadoline has been granted priority review status by the FDA.

Rights to the drug were acquired by Actavis along with its $25 billion acquisition of Forest Laboratories, which in turn had bought eluxadoline’s originator Furiex Pharmaceuticals for around $1.1 billion in cash, and up to $30 per share (about $360 million in aggregate) in a contingent value right (CVR), with the aim of expanding its gastro-intestinal business (The Pharma Letter April 29).