FDA Approves First Generic of Common Albuterol Inhaler

The US Food and Drug Administration have approved the first generic of Proventil HFA (albuterol sulfate) Metered Dose Inhaler, 90 mcg/Inhalation, for the treatment and prevention of bronchospasm in patients with reversible obstructive airway disease who are aged 4 years or older. It is also approved to prevent exercise-induced bronchospasms in the same age group.

The most common adverse effects associated with the use of albuterol sulfate Metered Dose Inhaler, 90 mcg/Inhalation are upper respiratory tract infection, rhinitis, nausea, vomiting, tachycardia, tremor, and nervousness.

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

—Michael Potts

Reference:
FDA Approves First Generic of a Commonly Used Albuterol Inhaler to Treat and Prevent Bronchospasm. News release. US Food and Drug Administration. April 8, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-commonly-used-albuterol-inhaler-treat-and-prevent-bronchospasm.