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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:  05/17/2011
 
Trade Name:  Faslodex Injection
 
Generic Name or Proper Name (*):  fulvestrant
 
Indications Studied:  Use in girls with progressive precocious puberty associated with McCune-Albright Syndrome
 
Label Changes Summary:  * Efficacy has not been demonstrated in girls with McCune-Albright Syndrome associated with progressive precocious puberty* Information on dosing, adverse reactions, pharmacokinetics and clinical trial
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  AstraZeneca
 
Pediatric Exclusivity Granted Date:  02/01/2011
 
NNPS:  FALSE
 
Therapeutic Category:  Estrogen lowering agent
 
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