Cipla obtains FDA approval for generic Proventil HFA
A first generic of a commonly used albuterol inhaler is now available to treat or prevent bronchospasm.
The Food and Drug Administration has cleared Cipla’s generic Proventil HFA (albuterol sulfate) Metered Dose Inhaler, 90 mcg/Inhalation.
The product, which is the generic of Merck, Sharp & Dohme's Proventil HFA, is indicated for patients four years of age and older who have reversible obstructive airway disease, as well as for the prevention of exercise-induced bronchospasm in this age group.
“The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic," said FDA commissioner Stephen Hahn. "We remain deeply committed to facilitating access to medical products to help address critical needs of the American public."
According to the National Heart, Lung, and Blood Institute, bronchospasms occur when the muscles surrounding the airways swell and tighten, causing them to squeeze the airways and make them smaller. Exercise and other physical activity can bring on symptoms in most people who have asthma and may occur either during or right after being active.