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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. During 2007, approximately 11.7 million prescriptions were dispensed for clonidine hydrochloride tablets and approximately 1.8 million for clonidine patches.

Addrenex, based in Durham, North Carolina and formed in 2006, is a focused, specialty pharmaceutical company that develops and commercializes drugs to treat adrenergic dysregulation. Adrenergic dysregulation refers to abnormal neuronal activation or secretion of adrenaline/noradrenaline both at baseline and in response to external stress, as well as the resulting physiological effects. Excessive adrenergic stimulation (or understimulation) results in a host of symptoms; in ADHD the symptoms include stress/frustration intolerance, impulsivity, emotional explosiveness, and physical aggression to name a few.

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