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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
Sponsor:  Unimed
Pediatric Exclusivity Granted Date:  08/22/2007
Therapeutic Category:  Androgen-anabolic steroid