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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:  04/23/2014
 
Trade Name:  Kuvan
 
Generic Name or Proper Name (*):  sapropterin dihydrochloride
 
Indications Studied:  Treatment to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU)
 
Label Changes Summary:  Expanded indication to include 1 month to 4 years; previously approved for use in 4 years and older Safety and effectiveness have not been established in neonates Adversereactions observed in pediatric patients 1 month – 6 years were similar to adults except for an increased incidence of low Phe levels. 25% (16/65) experienced low Phe for age Information on adding crushed tablet or powder for oral solution to small amounts of soft food such as apple sauce Information on dosing, adverse reactions, PK parameters, and clinical trials
 
BPCA(B):  B
 
Sponsor:  BioMarin Pharmaceutical Inc.
 
Pediatric Exclusivity Granted Date:  03/13/2014
 
NNPS:  FALSE
 
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