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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:  04/20/2020
 
Trade Name:  Cymbalta
 
Generic Name or Proper Name (*):  duloxetine
 
Indications Studied:  Fibromyalgia in pediatric patients 13 to 17 years
 
Label Changes Summary:  Label Change Summary - Use for treatment of fibromyalgia in patients 13 to 17 years of age is supported by a 13-week placebo-controlled trial in 184 patients with juvenile fibromyalgia syndrome. - Cymbalta showed improvement over placebo on the primary endpoint, change from baseline to end-of-treatment on the Brief Pain Inventory (BPI) – Modified Short Form: Adolescent Version 24-hour average pain severity rating. - Safety and effectiveness for the treatment of fibromyalgia in patients less than 13 years of age have not been established. - Information on dosing, adverse reactions, and clinical trial. - Postmarketing study.
 
Product Labeling:  *Use for treatment of fibromyalgia in patients 13 to 17 years of age is supported by a 13-week placebo-controlled trial in 184 patients with juvenile fibromyalgia syndrome. *Cymbalta showed improvement over placebo on the primary endpoint, change from baseline to end-of-treatment on the Brief Pain Inventory (BPI) *Modified Short Form: Adolescent Version 24-hour average pain severity rating. *Safety and effectiveness for the treatment of fibromyalgia in patients less than 13 years of age have not been established. *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study.  Opens a new window
 
PREA(P):  P
 
Sponsor:  Eli Lilly
 
NNPS:  FALSE
 
Therapeutic Category:  Antidepressant
 
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