FDA accepts Addrenex’s new drug application for CloniBID

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of December 19, 2008. Upon FDA approval, Sciele expects to launch this product in early 2009.

In June 2007, Sciele licensed CloniBID from Addrenex Pharmaceuticals for the treatment of hypertension. CloniBID is a 12-hour, sustained-release formulation of clonidine hydrochloride.

Patrick Fourteau, CEO of Sciele Pharma, said: “Our partnership with Addrenex provides us with the opportunity to further expand and diversify our product portfolio, and we look forward to launching CloniBID for hypertension in early 2009.”