To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Accepts Supplemental Application For Astelin As Allergy Treatment In Children URL: http://www.pslgroup.com/dg/144AEA.htm Doctor's Guide November 10, 1999
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. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.