Intranasal corticosteroid receives FDA pregnancy Category B rating for allergi...( Wilmington DE August 26 2004 AstraZ...),Health

Wilmington, DE August 26, 2004 AstraZeneca announced today that the U.S. Food and Drug Administration (FDA) has approved revised labeling for its anti-inflammatory corticosteroid nasal spray RHINOCORT AQUA (budesonide). The new labeling upgrades RHINOCORT AQUA's pregnancy rating to Category B for the treatment of allergic rhinitis.

The achievement of a Category B rating indicates that adequate studies in pregnant women have demonstrated that treatment with RHINOCORT AQUA does not increase the risk of congenital malformations to the fetus during the first trimester of pregnancy and in later trimesters. This may give physicians greater confidence in prescribing a particular medication for women of child-bearing age or during pregnancy.

The FDA's pregnancy category rating system provides guidance to help physicians who prescribe medications to pregnant women. RHINOCORT AQUA is the first and only intranasal corticosteroid product for the treatment of allergic rhinitis in the United States to receive a Category B rating. All other intranasal corticosteroids approved by the FDA for the treatment of allergic rhinitis are rated Pregnancy Category C.

"AstraZeneca is a committed leader in the research and development of respiratory therapies and we are pleased to share this important information about the relative safety of RHINOCORT AQUA when women who are pregnant use our product," said William Mezzanotte, MD, Executive Director, Clinical Research. "This revised labeling for RHINOCORT AQUA should provide reassurance to patients who are, or who may become pregnant, and also need to control symptoms of allergic rhinitis."

The FDA based its pregnancy category label change for RHINOCORT AQUA upon a review of data from three Swedish birth registries. These registries covered over 2,000 births from 1995-2001 (Swedish Medical Birth Registry, Registry of Congenital Malformations, and Child Cardiology Registry). The data indicate no incre
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Contact: Edward Weirauch
edward.weirauch@astrazeneca.com
302-885-1977
Burson-Marsteller
26-Aug-2004

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