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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:  06/13/2014
 
Trade Name:  Jetrea
 
Generic Name or Proper Name (*):  ocriplasmin
 
Indications Studied:  Adjunct to vitrectomy
 
Label Changes Summary:  *The use of Jetrea in pediatric patients is not recommended. *A single center, placebo controlled, clinical study to investigate a single intravitreal injection of ocriplasmin in pediatric patients as an adjunct to vitrectomy was conducted in 24 eyes of 22 patients. * There were no statistical or clinical differences between groups for the induction of total macular PVD, any of the secondary endpoints or adverse events. *Postmarketing study.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  ThromboGenics, Inc.
 
NNPS:  FALSE
 
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