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Cipher receives FDA approval for Lipofen (CIP-Fenofibrate)
MISSISSAUGA, CANADA -- January 13, 2006 -- Cipher Pharmaceuticals Inc. today announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for CIP-Fenofibrate, the Company's novel formulation of the active ingredient fenofibrate, which is used in the treatment of hyperlipidemia.
CIP-Fenofibrate, approved under the label as Lipofen(TM), targets a large and growing market as the three existing novel fenofibrate formulations are forecasted to exceed $1 billion in annual U.S. sales.
"CIP-Fenofibrate is the first product from our pipeline to successfully receive FDA approval and we are actively pursuing opportunities to secure a U.S. commercial distribution agreement," said Larry Andrews, President of Cipher Pharmaceuticals. "CIP-Fenofibrate is one of three late-stage products in our pipeline. With an application for CIP-Isotretinoin under review with the FDA and preparations underway to file the CIP-Tramadol application with the FDA in the first half of 2006, we believe that the approval of CIP-Fenofibrate represents the first of a number of significant milestone events for Cipher."
CIP-Fenofibrate received approval for three unique fenofibrate dosages: 50, 100 and 150 mg, with the 150 mg strength equivalent to Tricor(R) 160 mg under fed conditions. With CIP-Fenofibrate, the extent of absorption is increased under high-fat conditions relative to low-fat conditions.
The approval provides for the use of CIP-Fenofibrate as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total-cholesterol (Total-C), triglycerides, apolipoprotein B (Apo B), and to increase high-density lipoprotein (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Frederickson Type IIa, IIb) in addition to the treatment of adult patients with hypertriglyceridemia (Frederickson Types IV and V hyperlipidemia).
SOURCE: Cipher Pharmaceuticals Inc.
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