Colesevelam Blog

Once-Daily Welchol (colesevelam HCl) for Oral Suspension Receives FDA Approval To be Mixed With Fruit Juice or Diet Soft Drinks

Posted 25 Jul 2011 by Drugs.com

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 ... Read more

Related support groups: Diabetes, Type 2, Welchol, Colesevelam, Hyperlipidemia