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FDA Accepts Supplemental Application For Astelin As Allergy Treatment In Children CRANBURY, NJ -- November 10,1999 -- Wallace Laboratories announced that the U.S. Food and Drug Administration has accepted for filing a supplemental New Drug Application (sNDA) requesting that Astelin® (azelastine HCI) Nasal Spray 137 mcg be used to treat pediatric patients, five to 11 years of age, with seasonal allergic rhinitis (SAR) at a daily dosage of one to two sprays per nostril twice a day. Azelastine nasal spray is currently approved for use in Europe for the treatment of symptoms of allergic rhinitis in adults and in pediatric patients six years of age and over at a dosage of 0.55 mg/day (one spray/nostril twice a day). In the United States, Astelin (azelastine HCI) Nasal Spray 137 mcg is approved for the treatment of symptoms of SAR in patients 12 years of age and older at a dosage of 1.1 mg/day (two sprays/nostril twice a day). Support for the requested expanded labeling is based on European and U.S. pediatric data. Astelin Nasal Spray is manufactured by Wallace Labs, a division of Carter Wallace, Inc. Related Links: Astelin (azelastine HCI) and Wallace Labs, a division of Carter Wallace, Inc. E-mail this page to a friend or colleague! To print, use this version