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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:
03/24/2008
Trade Name:
Depakote ER Depakote Sprinkles
Generic Name or Proper Name (*):
divalproex disodium
Indications Studied:
Pediatric Bipolar Disorder; Prophylaxis of Migraine
Label Changes Summary:
Efficacy was not established in a double-blind, placebo controlled study of patients 10-17 years conducted to evaluate efficacy in the treatment of pediatric bipolar disorder Efficacy was not established in a double-blind, placebo-controlled study of patients 12 17 years conducted to evaluate the efficacy in the prophylaxis of migraine The safety and tolerability was similar to adults in 5 long-term safety studies Additional information on clinical studies, AE profile in Depakote ER labeling
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Abbott
Pediatric Exclusivity Granted Date:
12/14/2007
NNPS:
FALSE'
Therapeutic Category:
Anticonvulsant; Mood Stablizer
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