• 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:  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
Sponsor:  AstraZeneca
Pediatric Exclusivity Granted Date:  02/01/2011
Therapeutic Category:  Estrogen lowering agent