Lupron Depot-PED Labeling Updated to Include 18 Year Data

Abbott announced that the FDA has approved a supplemental New Drug Application (NDA) for Lupron Depot-PED (leuprolide acetate for depot suspension) 1-month formulation. Lupron Depot-PED is indicated for the treatment of central precocious puberty. The labeling for Lupron Depot-PED now includes long-term (18 years) data, including pre-specified outcome results on puberty, height and reproductive function.

Abbott’s submission was supported by an open-label study that enrolled 55 patients who were assessed for signs and symptoms of puberty, luteinizing hormone (LH), height and reproductive function. During treatment with Lupron Depot-PED, clinical signs and symptoms of puberty were suppressed and normalized growth rates were achieved in most patients. Forty children continued in the post-treatment follow-up period. Six months after treatment stopped, puberty resumed and 87.9% of patients achieved LH levels in the puberty range. Thirty-three subjects were observed until they achieved final or near final adult height. Results showed that patients experienced an average height gain over predicted adult height before treatment. In a post-treatment survey of 20 females (ages 18–26), 80% reported normal menstrual cycles, and seven of these females reported pregnancies.

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