AstraZeneca’s Symbicort this week received an OK from the Food and Drug Administration for six months of pediatric exclusivity for the Symbicort Inhalation Aerosol.
The FDA’s decision was based on the evaluation of trials conducted in children with asthma from ages six to 12 years in response to a written request.
Symbicort is currently approved in the US to treat asthma in patients 12 years and older and for the maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD) in adults.
Symbicort is a combination formulation containing budesonide, an inhaled corticosteroid (ICS), and formoterol, a long-acting beta2-agonist bronchodilator (LABA), in a single inhaler.
The drug was first launched in Sweden in 2000 and has been approved in approximately 120 countries to treat asthma and/or COPD. Symbicort Inhalation Aerosol was first approved by the FDA in the US in July 2006 for the treatment of asthma in patients 12 years and older.
Sales of the inhaled formula totaled about $773 million in the first nine months of this year, down slightly from a year ago. The company cited competition and rebates in reporting the lower sales.
Symbicort is widely advertised for use in older adults with COPD, a lung condition usually linked to a history of smoking.
AstraZeneca employs about 1,500 in Delaware. It operates a distribution hub near Newark and an administrative headquarters in north Wilmington.
AZ recently announced job cuts in the wake of declining sales brought on by the end of patent protection for many of its previous blockbuster drugs.
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