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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:  12/27/2007
Trade Name:  AndroGel
Generic Name or Proper Name (*):  testosterone
Indications Studied:  Use in adolescent boys with delayed puberty
Label Changes Summary:  * Safety and efficacy in males < 18 years old have not been established * Improper use may result in acceleration of bone age and premature closure of epiphyses
Product Labeling:  Labeling  Opens a new window
Sponsor:  Unimed
Pediatric Exclusivity Granted Date:  08/22/2007
Therapeutic Category:  Androgen-anabolic steroid