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FDA OKs Generic Asthma Inhaler in Face of Coronavirus-Related Shortages
  • Robert Preidt
  • Posted April 8, 2020

FDA OKs Generic Asthma Inhaler in Face of Coronavirus-Related Shortages

The first generic albuterol inhaler in the United States was approved Wednesday by the U.S. Food and Drug Administration in response to inhaler shortages caused by the coronavirus pandemic.

The inhalers are widely used by people with asthma, but it's become more difficult to get them because they're being used to treat patients with COVID-19.

"The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic," FDA Commissioner Dr. Stephen Hahn said in an agency news release.

"We remain deeply committed to facilitating access to medical products to help address critical needs of the American public," he added.

Manufacturer Cipla Limited received approval for the first generic version of Proventil HFA (albuterol sulfate) Metered Dose Inhaler for the treatment or prevention of bronchospasms in patients aged 4 and older who have reversible obstructive airway disease, as well as the prevention of exercise-induced bronchospasms in this age group, the FDA said.

Bronchospasms occur when the muscles surrounding the airways swell and tighten, causing restriction of the airways, according to the U.S. National Heart, Lung, and Blood Institute.

Exercise and other physical activity can trigger symptoms in many people who have asthma and may occur either during or immediately after being active.

Albuterol helps open up the airways and is considered a "rescue" medication for people with asthma.

There are shortages of albuterol inhalers in some parts of the United States, and the shortages may spread, according to the American College of Allergy, Asthma and Immunology (ACAAI).

Patients with COVID-19 were initially treated with nebulizers, a common therapy for breathing problems that's used in hospitals, and sometimes at home.

However, research suggests that when aerosolized, the coronavirus could remain in the air for a while, and some nebulizers might spread the virus particles in the air, said Dr. Michael Blaiss, executive medical director of the ACAAI.

To be safe, many hospitals have started using albuterol inhalers to treat COVID-19 patients.

More information

The American Lung Association has more on asthma medications.

SOURCE: U.S. Food and Drug Administration, news release, April 8, 2020
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