WASHINGTON — The FDA approved the first generic alternative to the Proventil HFA (albuterol sulfate) Metered Dose Inhaler, 90mcg/Inhalation, for the treatment or prevention of bronchospasm in patients 4 years and older.
The FDA recently approved a generic of another albuterol inhaler, the PROAIR HFA, in February. But now, as the Covid-19 pandemic rages on and albuterol inhalers are increasingly used to help manage symptoms, these inhalers are in short supply.
With this new approval, the albuterol sulfate metered dose inhaler, 90mcg/inhalation, will be available to treat bronchospasms associated with reversible obstructive airway disease, as well as the exercise-induced bronchospasms associated with asthma.
“The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic,” said FDA Commissioner Stephen M Hahn, MD, in a statement. “We remain deeply committed to facilitating access to medical products to help address critical needs of the American public.”
According to the FDA, the most common side effects associated with this 90 mcg/inhalation albuterol sulfate metered dose inhaler are upper respiratory tract infection, rhinitis, nausea, vomiting, tachycardia, tremor, and nervousness.
This generic albuterol sulfate inhalation aerosol is manufactured by Cipla Limited.
