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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  08/21/2013
 
Trade Name:  Lysteda
 
Generic Name or Proper Name (*):  tranexamic acid
 
Indications Studied:  Treatment of cyclic heavy menstrual bleeding
 
Label Changes Summary:  Indicated for women of reproductive age. It is not intended for use in premenarcheal girls Information on PK studyPostmarketing study
 
Product Labeling: