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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:  10/18/2012
Trade Name:  Cymbalta
Generic Name or Proper Name (*):  duloxetine hydrochloride
Indications Studied:  Treatment for Major Depressive Disorder (MDD)
Label Changes Summary:  *Efficacy was not demonstrated in two 10-week, placebo-controlled trials with 800 pediatric patients with MDD, age 7-17 *Duloxetine has not been studied in pediatric patients less than 7 years *Decreased appetite and weight loss have been observed in association with the use of SSRIs and SNRIs. Pediatric patients treated with duloxetine in MDD clinical trials experienced a 0.2 kg mean decrease in weight at 10-weeks, compared with a mean weight gain of approximately 0.6 kg in placebo-treated patients. The proportion of patients who experienced a clinically significant decrease in weight (>3.5%) was greater in the duloxetine group than in the placebo group (11% and 6%, respectively). Subsequently, over the six-month uncontrolled extension period, most duloxetine treated patients trended toward recovery to their expected baseline weight. Perform regular monitoring of weight and growth in children and adolescents treated with an SNRI such as duloxetine *In the 2 pediatric MDD studies, the safety findings were consistent with the known safety and tolerability profile for duloxetine *Information on clinical trial, pharmacokinetics, and juvenile animal study
Product Labeling:  Labeling  Opens a new window
BPCA(B) and PREA(P):  B,P
Sponsor:  Lilly
Pediatric Exclusivity Granted Date:  07/10/2012
NNPS:  False
Therapeutic Category:  Antidepressant