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The FDA approved a pressurized metered-dose inhaler formulation of flunisolide (Aerospan HFA) for the maintenance treatment of asthma as prophylactic therapy in patients 6 years of age and older. It is also indicated to reduce or eliminate the need for oral corticosteroid therapy in asthmatic patients. The new formulation is propelled using hydrofluoroalkanes (HFAs) rather than chlorofluorocarbons (CFCs), which deplete the ozone layer.

 

The approval was based on data from 12-week clinical studies in adults and children showing that the HFA and CFC formulations were similarly efficacious for maintaining lung function.

 

Recommended doses of the HFC formulation are lower than those for the CFC aerosol. Patients switching from the CFC product to the HFA aerosol should be dosed appropriately according to the recommendations above and monitored to ensure that the selected dose is safe and efficacious.

 

Aerospan HFA is a product of Forest Laboratories.