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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
Sponsor:  Shire
Pediatric Exclusivity Granted Date:  05/25/2004
Therapeutic Category:  Hematology/Coagulation