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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:  12/10/2004
 
Trade Name:  Agrylin
 
Generic Name or Proper Name (*):  anagrelide
 
Indications Studied:  Myeloproliferative disorders
 
Label Changes Summary:  * An open-label study evaluated PK/PD but not efficacy. * Information on PK/PD profile, dosing, AEs, and safety in patients > 6 years to 17 years * No overall difference in dosing and safety were observed between pediatric and adult patients * Established recommended starting dose based on limited data. Dosage should be adjusted to the lowest effective dosage
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Shire
 
Pediatric Exclusivity Granted Date:  05/25/2004
 
NNPS:  FALSE
 
Therapeutic Category:  Hematology/Coagulation
 
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