FDA Approves First Albuterol Sulfate Inhaler Generic

The US Food and Drug Administration (FDA) has approved the first generic for albuterol sulfate (Proventil HFA) metered dose inhaler 90 mcg, for the treatment or prevention of bronchospasm 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, which commonly begins during childhood, afflicts more than 26 million Americans—7 million of which are children. Particularly during the ongoing coronavirus 2019 (COVID-19) pandemic, the FDA is recognizing a pronounced need for albuterol products.

“We remain deeply committed to facilitating access to medical products to help address critical needs of the American public,” FDA commissioner Stephen M. Hahn, MD, said in a statement.

Common adverse effects associated with albuterol sulfate 90 mcg include upper respiratory tract infection, rhinitis, nausea, vomiting, tachycardia, and more.

The generic approval comes a month following the FDA’s revised product-specific guidance for proposed albuterol sulfate metered dose inhalers, which included products referencing Proventil HFA. The guidance advises on bioequivalence recommendations for generic candidates, among other qualifications.

Generic applicants are required to submit appropriate data and information demonstrating complex generic drug-device combination products such as that for albuterol sulfate metered dose inhalers meet the FDA’s standards for initial drug approvals—so as to ensure equal safety and efficacy to brand-name equivalents.