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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:  07/28/2010
 
Trade Name:  Lastacaft Ophthalmic Solution
 
Generic Name or Proper Name (*):  alcaftadine
 
Indications Studied:  Prevention of itching associated with allergic conjunctivitis.
 
Label Changes Summary:  * Safety and effectiveness in patiente 2 years were established in controlled clinical trials * Safety and effectiveness in pediatric patients< 2 years have not been established * New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Vistakon Pharmaceuticals,
 
NNPS:  FALSE
 
Therapeutic Category:  Antihistamine, topical
 
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