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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:  12/08/2017
 
Trade Name:  Omidria intraocular solution
 
Generic Name or Proper Name (*):  phenylephrine and ketorolac
 
Indications Studied:  Prevention of intraoperative miosis and reduction of postoperative pain in patients who have undergone cataract surgery
 
Label Changes Summary:  *Safety and effectiveness have been established in the pediatric population from neonates to adolescents (birth to younger than 17 years). * Use in this population is supported by evidence from adequate and well-controlled studies of Omidria in adults with additional data from a single active-controlled safety study in pediatric patients up to 3 years old. *The safety profile in children was similar to that observed in adults. *Information on adverse reactions and clinical trials.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Omeros Corporation
 
NNPS:  FALSE
 
Therapeutic Category:  Analgesic, topical
 
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