FDA approves first Proventil HFA generic for bronchospasm

The FDA has approved the first generic of Proventil HFA metered-dose inhaler — albuterol sulfate — for treatment or prevention of bronchospasm in reversible obstructive airway disease and prevention of exercise-induced bronchospasm in patients aged at least 4 years, according a press release.

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

Approval of this generic of Proventil HFA metered-dose inhaler, 90 µg per inhalation (Merck), was granted to Cipla Limited.

The release also stated that the FDA issued revised draft product-specific guidance in March for proposed generic albuterol sulfate metered-dose inhalers, including drug products referencing Proventil HFA.

As Healio Pulmonology previously reported, the FDA approved the first ProAir HFA generic, an albuterol inhalation aerosol, in February.