FDA Approves Generic Albuterol Sulfate Inhalation Aerosol

Officials with the FDA have approved the first generic for 1 of the most commonly used aerosol rescue inhalers, albuterol sulfate (ProAir HFA Inhalation Aerosol), indicated for the treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease.¹

The new approval was awarded to Perrigo Company and its partner, Catalent Pharma Solutions. The generic inhaler is AB-rated, and is a metered-dose inhaler.²

Bronchospasms occur when the muscles surrounding the airways swell and tighten, causing wheezing and shortness of breath. Exercise and other physical activity can lead to bronchospasms in most people with asthma.¹ More than 26 million people in the United States have asthma, including 7 million children.¹

Metered dose inhalers are known as complex generics, according to the FDA. These generics are more difficult to copy because of their complex formulation or mode of delivery, and as a result many complex drugs lack generic competition.¹ According to a press release from Perrigo, this is the first generic metered-dose inhaler to be approved by the FDA in over 20 years.²

The product will be immediately launched with limited commercial qualities, and manufacturers expect that there will be a steady supply by the fourth quarter of 2020.²

REFERENCES

• FDA approves first generic of ProAir HFA [news release]. White Oak, MD; February 24, 2020: FDA website. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-proair-hfa. Accessed February 25, 2020.
• Perrigo and Catalent Announce FDA Approval of Perrigo’s AB-Rated Generic Version of ProAir HFA [news release]. Dublin, Ireland, and Somerset, NJ; February 25, 2020: Perrigo website. https://www.perrigo.com/press-release/perrigo-and-catalent-announce-fda-approval-perrigos-ab-rated-generic-version-proairr. Accessed February 25, 2020.