March 02, 2020
Debbie Courson Smith/Pixabay
The FDA has approved the first generic albuterol sulfate inhaler, used to treat people with asthma.
The U.S. Food and Drug Administration has approved the first generic rescue inhaler to treat asthma.
The albuterol sulfate inhaler can be used to treat or prevent bronchospasms in patients four years of age and older who have a reversible obstructive airway disease, like asthma.
The brand name inhaler, ProAir HFA Inhalation Aerosol, is one of the most commonly used in the United States.
Bronchospasms occur when the airway muscles swell and contract, making it difficult to breathe. They often are triggered by exercise or other physical activity. The inhaler delivers medicine that opens up the airways, allowing people with asthma to breathe easier.
FDA Commissioner Dr. Stephen M. Hahn said in a statement that the inhaler's approval "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 market."
More than 25 million Americans have asthma, according to the Centers for Disease Control and Prevention. Asthma symptoms – difficulty breathing, wheezing, coughing and a tightness in the chest – are triggered by allergens or irritants that enter the lungs.
"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," Hahn added. "As a result, too many complex drugs lack generic competition even after exclusivities no longer block generic approval."
Side effects include headache, rapid heart rate, pain, dizziness, sore throat, rhinitis, chest pain, palpitations, tremor and nervousness.
The manufacturer, Perrigo Pharmaceuticals, is releasing a limited quantity of the product now but expects to have a steady supply ready by the end of the year.
