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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:  02/03/2011
 
Trade Name:  Makena
 
Generic Name or Proper Name (*):  hydroxyprogesterone caproate
 
Indications Studied:  Reduce the risk of preterm birth
 
Label Changes Summary:  * Safety and effectiveness in pediatric patients <16 years have not been established* A small number of women < 18 years were studied; safety and efficacy are expected to be the same in women aged 16 years and above as for users 18 years and older* Information on clinical trial
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Hologic, Inc.
 
NNPS:  TRUE
 
Therapeutic Category:  Progestin
 
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