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.
The details can be read here.
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