FDA Approves Generic Albuterol Inhaler for Bronchospasm

The FDA has approved Cipla Limited’s albuterol sulfate metered dose inhaler 90 mcg/inhalation as the first generic equivalent to Proventil HFA (Merck). This medication inhaler is indicated for the treatment or prevention of bronchospasm in patients ages 4 years and older who have reversible obstructive airway disease. In addition, it is intended for the prevention of exercise-induced bronchospasm in this age group.

The most common adverse effects associated with albuterol sulfate metered dose inhaler, 90 mcg/inhalation are upper respiratory tract infection, rhinitis, nausea, vomiting, rapid heart rate, tremor, and nervousness.

"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."

Bronchospasms occur when the muscles surrounding the airways swell and tighten, causing them to squeeze the airways and make them smaller. Physical activity, such as exercise, can bring on the symptoms in most people who have asthma, and may occur either during or right after being active.

REFERENCE

FDA approves first generic of a commonly used albuterol inhaler to treat and prevent bronchospasm [news release]. Silver Spring, MD; April 8, 2020: FDA website. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-commonly-used-albuterol-inhaler-treat-and-prevent-bronchospasm. Accessed April 9, 2020.