July 25, 2011
New Dosing Options for Welchol for Oral Suspension ApprovedThe FDA has approved the supplemental New Drug Application for Welchol (colesevelam HCl; Daiichi Sankyo) for Oral Suspension to be mixed with fruit juice or diet soft drinks. Welchol for Oral Suspension was first approved in 2009 to be mixed with water.
Welchol is indicated as an adjunct to diet and exercise to reduce elevated LDL-C in adults with primary hypercholesterolemia (Type IIa), alone or with a statin, when response to nondrug therapy is inadequate; and to reduce LDL-C in boys and postmenarchal girls 10–17yrs of age with heterozygous familial hypercholesterolemia, alone or with a statin after failing an adequate trial of diet therapy. Welchol is also indicated as an adjunct to diet and exercise in type 2 diabetes in combination with metformin, sulfonylureas, or insulin.
For more information call (877) 437-7763 or visit www.welchol.com.