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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 study*Postmarketing study
 
Product Labeling:    Opens a new window
 
PREA(P):  P
 
Sponsor:  Ferring
 
NNPS:  FALSE
 
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