April 22, 2008 - Sciele Pharma, Inc. (NASDAQ:SCRX) today announced that the U.S. Food & Drug Administration (FDA) has accepted the New Drug Application (NDA) submitted by Addrenex Pharmaceuticals for CloniBID to treat hypertension. 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, the Company licensed CloniBID from Addrenex Pharmaceuticals for the treatment of hypertension. CloniBID is a 12-hour, sustained-release formulation of clonidine hydrochloride.
Clonidine hydrochloride, the active ingredient in CloniBID, is a centrally acting alpha-2 agonist approved for the treatment of hypertension. During 2007, approximately 11.7 million prescriptions were dispensed for clonidine hydrochloride tablets and approximately 1.8 million prescriptions were dispensed for clonidine patches, according to IMS Health's National Prescription Audit Plus data.
Patrick Fourteau, Chief Executive Officer of Sciele Pharma, said, "We are very excited about this new development and congratulate Addrenex on the acceptance of this NDA by the FDA. 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."
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