The first generic version of ProAir HFA (albuterol sulfate; Teva) has been approved by the Food and Drug Administration (FDA). 

The FDA granted approval of Albuterol Sulfate Inhalation Aerosol to Perrigo and its partner, Catalent Pharma Solutions. The Company is launching a limited supply of the AB-rated product and expects to have a steady supply by the fourth quarter of 2020. 

Albuterol Sulfate Inhalation Aerosol is indicated in patients 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm. 

“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,” said FDA Commissioner Stephen M. Hahn, MD. “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.”

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The generic product contains 200 metered inhalations (90mcg/actuation) and includes a dose counter like the reference product.

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