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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:  02/08/2002
Trade Name:  Acular & Acular PF
Generic Name or Proper Name (*):  ketorolac
Indications Studied:  Relief of ocular itching due to seasonal allergic rhinitis and postoperative inflammation after cataract extraction
Label Changes Summary:  * Safety and effectiveness established down to 3 years; previously approved down to 12 years
Product Labeling:  Labeling  Opens a new window
Sponsor:  Allergan
Pediatric Exclusivity Granted Date:  09/06/2001
Therapeutic Category:  Anti-inflammatory