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News From the Food and Drug Administration
May 19, 2020

Generic Albuterol Inhaler Approved

JAMA. 2020;323(19):1887. doi:10.1001/jama.2020.7282

The FDA has approved the first generic version of Proventil HFA Metered Dose Inhaler, 90 μg per inhalation, to treat or prevent bronchospasm in patients aged 4 years or older who have reversible obstructive airway disease. The generic albuterol sulfate inhaler also is indicated for exercise-induced bronchospasm prevention in the same age group.

The agency “recognizes the increased demand for albuterol products during the novel coronavirus pandemic,” FDA Commissioner Stephen Hahn, MD, said in a statement. Shortages of the inhalers were reported last month as they increasingly were used to help patients with diagnosed or suspected coronavirus disease 2019 breathe more easily.

Also last month, the FDA issued specific guidance for developing generic albuterol sulfate metered dose inhalers, including those that have Proventil HFA as their reference product. The draft document set out recommendations for in vitro and in vivo studies to establish bioequivalence of generic versions with their reference products.

Metered dose inhalers are complex combination products consisting of a drug and a device that can be more challenging than solid oral formulations like tablets to develop as generics. Therefore, the FDA assists industry in developing these products by meeting with individual companies to help smooth the review process and publishing guidance documents that explain how to complete applications for generic approvals.