FDA approves generic version of Albuterol inhaler in view of Covid 19 pandemic

The U.S. Food and Drug Administration has approved the first generic of albuterol sulfateMetered Dose Inhaler, 90 mcg/Inhalation, for the treatment or prevention of bronchospasm in patients four years of age and older who have reversible obstructive airway disease or prevention of exercise-induced bronchospasm in patients aged 4 years and older.

The generic approval for the inhalation aerosol was granted to Cipla Limited.

Asthma afflicts more than 26 million Americans—7 million of which are children.

"The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic," said FDA Commissioner Stephen M. Hahn, M.D. "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. Asthma causes recurring periods of wheezing (a whistling sound when breathing), chest tightness, shortness of breath and coughing. The coughing often worsens at night or early in the morning. Asthma affects people of all ages, but it most often starts during childhood. In the United States, more than 26 million people are known to have asthma, about 7 million of these people are children.