Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
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]  Opens a new window
 
PREA(P):  P
 
Sponsor:  Daiichi Sankyo
 
NNPS:  FALSE
 
Therapeutic Category:  Antilipemic
 
-
-