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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
Welchol (colesevelam HCl) Receives FDA Approval to Lower LDL Cholesterol in Pediatric Patients with Heterozygous Familial Hypercholesterolemia
Posted 2 Dec 2009 by Drugs.com
Welchol for Oral Suspension Also Approved by FDA PARSIPPANY, N.J., Oct. 7 /PRNewswire/ – Daiichi Sankyo, Inc. (DSI) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Welchol (colesevelam HCl) to be used as an adjunct to diet and exercise for the reduction of elevated low-density lipoprotein cholesterol (LDL-C) in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (heFH) alone or in combination with a statin after failing an adequate trial of diet therapy. Originally approved in 2000 for LDL-C lowering and in 2008 for A1C reduction in adults, Welchol is approved as an adjunct to diet and exercise to reduce elevated LDL-C in adults with primary hyperlipidemia and improve glycemic control in adults with type 2 diabetes mellitus. Familial hypercholesterolemia (FH) ... Read more
Related support groups: Welchol, Heterozygous Familial Hypercholesterolemia
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Related Condition Support Groups
Diabetes, Type 2, High Cholesterol, Diarrhea, Chronic, Hyperlipoproteinemia Type IIa (Elevated LDL), Hyperlipoproteinemia