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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:  09/18/2009
 
Trade Name:  AndroGel
 
Generic Name or Proper Name (*):  testosterone
 
Indications Studied:  Use in adolescent boys with delayed puberty
 
Label Changes Summary:  * New safety information added to labeling including a Boxed Warning, and revisions to the Warnings and Precautions, Adverse Reactions, and Patient Counseling sections on the risk of virilization from secondary exposure of children to testosterone due to drug transfer from unwashed or uncovered application skin sites of adult males using testosterone gel products * Safety and efficacy have not been established in males < 18 years
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Unimed
 
Pediatric Exclusivity Granted Date:  08/22/2007
 
NNPS:  TRUE
 
Therapeutic Category:  Androgen-anabolic steroid
 
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