FDA Clears First Generic Proventil Inhaler

Cipla has received the FDA’s first approval for a generic Proventil HFA (albuterol sulfate) metered-dose inhaler for treating or preventing bronchospasms in patients age four years and older with reversible obstructive airway disease.

The agency cited the importance of albuterol products during the COVID-19 crisis in its announcement of the approval. The 90mcg inhaler also received clearance for preventing exercise-induced bronchospasms in the same age group.

FDA Commissioner Stephen Hahn said the agency “recognizes the increased demand for albuterol products during the novel coronavirus pandemic.”