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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:  05/06/2011
Trade Name:  Plavix
Generic Name or Proper Name (*):  clopidogrel bisulfate
Indications Studied:  Reduction of the incidence of thrombosis in children with systemic to pulmonary artery shunts for palliation of cyanotic congenital heart disease
Label Changes Summary:  * Safety and effectiveness in pediatric populations have not been established* A randomized, placebo-controlled trial did not demonstrate a clinical benefit in neonates and infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt.
Product Labeling:  Labeling  Opens a new window
Sponsor:  Sanofi Aventis
Pediatric Exclusivity Granted Date:  01/20/2011
Therapeutic Category:  Platelet inhibitor