WASHINGTON — The FDA approved the first generic version of the Proventil HFA albuterol inhaler, citing increased demand for this type of product as a treatment for COVID-19.
The metered dose inhaler, made by Cipla Ltd., delivers 90 μg albuterol sulfate per puff; the approved indication is for “treatment or prevention of bronchospasm in patients four years of age and older who have reversible obstructive airway disease, as well as the prevention of exercise-induced bronchospasm in this age group,” according to an FDA statement.
“The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic,” said FDA Commissioner Stephen M. Hahn, MD, in the statement.
On March 20, the American College of Allergy, Asthma, and Immunology warned of albuterol inhaler shortages in some parts of the country, “because of the increased use of albuterol inhalers in hospitals for COVID-19 and suspected COVID-19 patients to help with respiratory issues.”