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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
02/12/2020
Trade Name:
Doryx; Doryx MPC
Generic Name or Proper Name (*):
doxycycline hyclate
Indications Studied:
Postmarketing study
Label Changes Summary:
*Population pharmacokinetic analysis of sparse concentration-time data of doxycycline following standard of care intravenous and oral dosing in 44 children (2-18 years of age) showed that allometrically-scaled clearance of doxycycline in children =2 to =8 years did not differ significantly from children >8 to 18 years. *No clinically significant difference in CL differences between oral and IV were observed in the small cohort of pediatric patients who received the oral (N=l9) or IV (N=21) formulation alone. *Off-patent written request.
BPCA(B):
B
Sponsor:
Mayne Pharma International
NNPS:
FALSE
Therapeutic Category:
Antibiotic
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