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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:  01/31/2020
 
Trade Name:  Viibryd
 
Generic Name or Proper Name (*):  vilazodone hydrochloride
 
Indications Studied:  Major depressive disorder (MDD)
 
Label Changes Summary:  *Safety and effectiveness have not been established in pediatric patients for the treatment of MDD. *Efficacy was not demonstrated in two adequate and well controlled, 8-week studies including a total of 1002 pediatric patients ages 7 years to 17 years of age with MDD. *The following adverse reactions were reported in at least 5% of pediatric patients treated with Viibryd and occurred at a rate at least twice that for pediatric patients receiving placebo: nausea, vomiting, diarrhea, abdominal pain/discomfort, and dizziness. *Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients.
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  3M Drug Delivery Systems Division
 
Pediatric Exclusivity Granted Date:  01/21/2020
 
NNPS:  FALSE
 
Therapeutic Category:  Antidepressant
 
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