PARSIPPANY, N.J., July 25, 2011 /PRNewswire/ -- Daiichi Sankyo, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Welchol® (colesevelam HCl) for Oral Suspension to be mixed with fruit juice or diet soft drinks, offering a new option for adult patients with primary hyperlipidemia and type 2 diabetes. Welchol for Oral Suspension was first approved in 2009 to be mixed with water.
Welchol is currently the only product approved by the FDA, in addition to diet and exercise, to improve both glycemic control and LDL cholesterol (LDL-C or "bad" cholesterol) in adults with type 2 diabetes and high LDL cholesterol. Originally approved in 2000 for LDL-C lowering and in 2008 for A1C reduction in adults, a once-daily formulation of Welchol, Welchol for Oral Suspension, was approved by the FDA for both these indications in 2009. In addition, Welchol has a pediatric indication, specifically approved to reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia. Please see Important Information about Welchol below.
"Since the approval of once-daily Welchol for Oral Suspension, we've seen that patients appreciate the flexible dosing options provided by Welchol, taken as tablets with a meal and liquid, or as a drinkable formulation with a meal, to help them reach their LDL-C and A1C goals," said Oliseyenum M. Nwose, MBBS, MRCPath, Executive Medical Director, Medical Research and Strategy Therapeutic Areas Head, Hypertension and Metabolism at Daiichi Sankyo, Inc. "We are pleased that patients, depending on their preference, can now choose to mix their Welchol for Oral Suspension with fruit juice, diet soft drinks or water. Welchol for Oral Suspension is once-daily, sugar-free*, citrus-flavored and non-systemically absorbed, which means it is not metabolized in the liver or kidneys."
|SOURCE Daiichi Sankyo, Inc.|
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