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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
04/03/2019
Trade Name:
Welchol Chewable Bar
Generic Name or Proper Name (*):
colesevelam HCl
Indications Studied:
Reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia as monotherapy or in combination with a statin after failing an adequate trial of diet therapy
Label Changes Summary:
*New Chewable Bars: 3.75 gram per bar. *Information on dosing and administration. *New dosage form.
Product Labeling:
[INVALID]
PREA(P):
P
Sponsor:
Daiichi Sankyo
NNPS:
FALSE
Therapeutic Category:
Antilipemic
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