FDA Approves First Generic of Albuterol Sulfate Inhaler

April 8, 2020

The announcement follows recent albuterol shortages reports due to the COVID-19 pandemic.

The FDA has approved the first generic of albuterol sulfate (Proventil HFA) metered dose inhaler, 90 mcg/inhalation, to treat or prevent bronchospasms for patients 4 years of age and older with reversible obstructive airway disease and/or exercise-induced bronchospasm, according to a press release.

The announcement follows recent reports across the country identifying shortages of albuterol inhalers in hospitals due to the COVID-19 pandemic. Because of COVID-19 there has been increased allocation of albuterol inhalers for patients with or suspected to have COVID-19 infection due to concerns that nebulizers may help spread the virus in the air in hospitals. 

In the United States, more than 26 million individuals are known to have asthma, and approximately 7 million children are affected. Bronchospasm symptoms occur when the muscles surrounding a patient’s airways swell and tighten, making it difficult to breathe, according to the National Heart, Lung, and Blood Institute.

Common adverse effects associated with albuterol sulfate inhaler include upper respiratory tract infection, rhinitis, nausea, vomiting, rapid heart rate (tachycardia), tremor, and nervousness.

Companies are able to correspond with the FDA in conjunction with their pre-Abbreviated New Drug Application (ANDA) program under the Genetic Drug User Fee Amendments (GDUFA) to develop complex generic drug products. The FDA additionally has provided recommendations to companies on steps to take to complete applications for potential generic drug products.

“The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic,” FDA Commissioner Stephen M Hahn, MD, said in a statement. “We remain deeply committed to facilitating access to medical products to help address critical needs of the American public.”

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

References:

FDA Approves First Generic of a Commonly Used Albuterol Inhaler to Treat and Prevent Bronchospasm [news release]. FDA website. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-commonly-used-albuterol-inhaler-treat-and-prevent-bronchospasm?utm_campaign=040820_PR_FDA%20approves%20first%20generic%20of%20Proventil%20HFA&utm_medium=email&utm_source=Eloqua. Published April 8, 2020. Accessed April 8, 2020.