FDA approves first generic asthma inhaler

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More than 25 million Americans live with asthma, according to the Asthma and Allergy Foundation of America. That means that if you are in a room with 13 people, at least one person will likely be asthmatic.

The rate is even higher among kids, with a 2017 AAFA report estimating that one in 12 children aged 0–17 years had asthma. In a study published that year in the Annals of the American Thoracic Society, the average per-person medical cost of the condition was $3,266 a year, with $1,830 of that attributed to prescription medication.

Considering that millions of asthma sufferers fall below the federal poverty threshold, these costs can be prohibitive.

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Fortunately, the U.S. Food and Drug Administration has approved the first generic asthma inhaler for patients who are at least 4 years old.

The new approval is for a generic version of ProAir HFA (albuterol sulfate) Inhalation Aerosol, which is a short-acting rescue inhaler used to treat and prevent asthma attacks. Those events see patients have a sudden constriction of the muscles in the walls of the bronchioles, severely limiting the ability to breathe.

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According to the prescription price comparison website GoodRx, the brand-name version of albuterol sulfate inhalation aerosol retails for more than $60, while the generic version can be purchased for $35. Prices may vary by location and pharmacy.

The FDA reports that generic options of asthma inhalers can be difficult to create, but are important to develop.

“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,” FDA Commissioner Dr. Stephen Hahn said in a statement.  “As a result, too many complex drugs lack generic competition even after patents and exclusivities no longer block generic approval.”

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There is currently only one manufacturer of generic Proair. However, prices could drop even more if other manufacturers release their own versions.

“Supporting development and approval of generic copies of these complex medicines so that these products can get to patients has been a major focus of our efforts to improve competition and access and to lower drug prices,” Hahn said. “Getting more generic copies of complex drugs to the market is a key priority for how we’ll help bring new savings to consumers.”

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Tricia Goss

Tricia is a professional writer and editor who lives in North Texas with her family and one smelly dog. She is a wannabe problem solver, junk food maven professional coffee practitioner, web guru and general communicator. Learn More.