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New Pediatric Labeling Information Database - Detail
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Pediatrics
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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