• 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:  03/04/2020
 
Trade Name:  Acticlate; Acticlate Cap
 
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) 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=19) or IV (N=21) formulation alone. *Off-patent written request.
 
BPCA(B):  B
 
Sponsor:  Almirall, LLC
 
NNPS:  FALSE
 
Therapeutic Category:  Antibiotic
 
-
-