FDA approves first generic of ProAir HFA inhalation aerosol

The US Food and Drug Administration (FDA) has apporved the first generic of ProAir HFA (albuterol sulfate) inhalation aerosol for the treatment or prevention of bronchospasm in patients four years of age and older with reversible obstructive airway disease as well as the prevention of exercise-induced bronchospasm in patients four years of age and older.

“Today’s approval of the first generic drug product for one of the most commonly used rescue inhalers in the US is part of our longstanding commitment to advance patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand name counterparts and to expand opportunities to bring generic copies of complex drugs to the market,” said FDA Commissioner Stephen Hahn. “Metered dose inhalers like these are known as complex generics, which are traditionally harder to copy because of their complex formulation or mode of delivery. As a result, too many complex drugs lack generic competition even after patents and exclusivities no longer block generic approval. Supporting the development and approval of generic copies of these medicines has been a major focus of our efforts to improve competition and access and to lower drug prices.”

Granted to Perrigo Pharmaceutical, the approval was granted after appropriate data and information submitted by the company demonstrated the generic drug-device combination met the agency’s standards, to ensure the medication is as safe and effective as its brand name counterpart.

The most common side effects associated with albuterol sulfate inhalation aerosol are headache, rapid heart rate (tachycardia), pain, dizziness, sore throat (pharyngitis), rhinitis, chest pain, palpitations, tremor and nervousness.