Amneal Pharmaceuticals has received US Food and Drug Administration approval for its albuterol sulfate inhalation aerosol, the generic equivalent to ProAir HFA.
The green light marks the company’s second approval for a complex respiratory medicine in the fourth quarter, following clearance for its generic version of QVAR.
The company said the latest milestone strengthens its move into advanced inhaled and respiratory drug delivery, backed by its manufacturing platform.
Dr Srinivas Kone, senior vice-president and chief scientific officer for affordable medicines, said the twin approvals reflect “years of hard work, engineering excellence and investment” and position the firm for both commercial growth and meaningful clinical impact.
The newly approved inhaler is indicated for the treatment or prevention of bronchospasm in adults and adolescents aged 12 and older with reversible obstructive airway disease.
Common adverse reactions include headache, tachycardia, pain, dizziness, pharyngitis and rhinitis.
US annual sales of albuterol sulfate inhalation aerosols totalled about $1.5bn for the 12 months to September 2025. That is roughly €1.35bn at current exchange rates.
Amneal wins FDA approval for generic albuterol inhaler
