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AstraZeneca
FDA approves RHINOCORT AQUA for use in pregnant women
September 24th, 2004
AstraZeneca announced 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, which means the medication is an appropriate option for pregnant women with nasal allergies.
The approval was based on evidence that the medication did not cause an increased risk of birth defects. All other medications in the class approved by the FDA for the treatment of allergic rhinitis are rated Pregnancy Category C.
The...
Source: Food & Drug Law Weekly (2004-09-24)
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