- Reference code :
- wf338
- Published date :
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09 August 2000
- Expired date :
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26 December 2027
AstraZeneca today announced that Pulmicort Respules (budesonide inhalation suspension), its new asthma medication for young children and infants, is now approved by the U.S. Food and Drug Administration (FDA). As the first and only asthma treatment approved for children and infants as young as 12 months, Pulmicort Respules represents an innovative approach to inhaled corticosteroid delivery in young children and is the first and only corticosteroid to be available as a nebulized formulation. Nebulization is a process that converts the liquid medication to a fine mist which the young child can inhale through a tiny facemask or mouthpiece. Previously, inhaled corticosteroid therapy was only available for children four years of age and older and typically administered with an asthma inhaler which young children often were not able to use properly.
Dr. Frank Casty, Executive Director, Respiratory and Inflammation at AstraZeneca confirmed that the development of Pulmicort Respules underscores the company's commitment to provide novel treatments for paediatric asthma. "Now with the approval of Pulmicort Respules, physicians and parents will have an important new therapy to help them manage paediatric asthma and reduce the symptoms associated with this disease," said Dr. Casty. Pulmicort Respules is a preventative medication that helps control asthma in infants and children from 12 months to eight years of age.
The FDA approval of Pulmicort Respules is based on data from three 12-week double-blind U.S. clinical studies involving 946 children 12 months to eight years of age with mild to moderate persistent asthma. Pulmicort Respules reduced the need for bronchodilators and improved the control of night and daytime asthma symptoms.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of $15 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products.
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