FDA clears generic asthma inhaler, inhaled corticosteroid

March 3, 2020

Inhaler is the first generic approval of its kind.

FDA cleared the first generic asthma inhaler of its type, along with generic inhaled corticosteroid powder.

The first generic of ProAir HFA (albuterol sulfate) Inhalation Aerosol (Perrigo Pharmaceutical) was approved for patients four years and older with reversible obstructive airway disease and the prevention of exercise-induced bronchospasm.

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“Today’s approval of the first generic drug product for one of the most commonly used rescue inhalers in the U.S. 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,” says FDA Commissioner Stephen M. Hahn, MD, in a press release.

Metered dose inhalers are known as complex generics, which are traditionally harder to copy because of their complex formulation or mode of delivery, Hahn says.

“As a result, too many complex drugs lack generic competition even after patents and exclusivities no longer block generic approval…Getting more generic copies of complex drugs to the market is a key priority for how we’ll help bring new savings to consumers,” he adds.

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Separately, FDA approved generic ArmonAir® Digihaler™ (fluticasone propionate) Inhalation Powder (Teva Respiratory LLC) an inhaled corticosteroid (ICS) delivered via Teva’s Digihaler™ device.

The ArmonAir® Digihaler contains built-in sensors and connects to a companion mobile application that provides information on inhaler use to people with asthma.

It is indicated for the maintenance treatment of asthma in patients 12 years and older.

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