Sciele Pharma, Inc. (SCRX) Receives FDA Approval for CloniBID
Sciele Pharma, Inc. (SCRX), headquartered in Atlanta, Georgia, recently announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) submitted by Addrenex Pharmaceuticals for CloniBID to treat hypertension. In June 2007, the company licensed CloniBID from Addrenex Pharmaceuticals for the treatment of hypertension. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of December 19, 2009. Upon FDA approval, Sciele expects to launch this product in early 2009. CloniBID is a 12-hour, sustained release formulation of clonidine hydrochloride, the active ingredient in CloniBID which is approved for the treatment of hypertension.…