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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:  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  Opens a new window
BPCA(B) and PREA(P):  B, P
Sponsor:  Abbott
Pediatric Exclusivity Granted Date:  12/14/2007
Therapeutic Category:  Anticonvulsant; Mood Stablizer