Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
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
 
-
-