New ProAir HFA Generic Approved

August 25, 2020 – The U.S. FDA has approved Albuterol Sulfate Inhalation Aerosol 90mcg (base)/ actuation, manufactured by Lupin, as a generic for Teva’s ProAir® HFA. The product is indicated to treat or prevent bronchospasm in patients at least four years old who have reversible obstructive airway disease, and to prevent exercise-induced bronchospasm in the same age group.

Obstructive airway diseases include conditions such as asthma, chronic obstructive pulmonary disease, cystic fibrosis, and bronchiolitis. These conditions make it difficult to breathe and can be life-threatening. Albuterol sulfate, which has been FDA approved since 1981, is a bronchodilator that opens constricted airways, helping patients breathe better.

Recommended dosing to treat or prevent bronchospasm is two inhalations every 4-6 hours. However, a single inhalation every four hours may be sufficient for some patients. To prevent exercise-induced bronchospasm, the recommended dose is two inhalations 15 to 30 minutes before exercise. The inhaler must be primed before its first use, and if it has not been used for more than two weeks. The actuator should be cleaned with warm water once a week (and dried thoroughly after). Once the dose counter displays “0” or the expiration date is reached, whichever comes first, the inhaler should be discarded. Each canister contains 200 actuations of medication.

Brand name ProAir HFA first received FDA approval in 2004 and has a wholesale acquisition cost (WAC) of $66.88 per inhaler. Lupin’s generic has launched at a WAC of $35.98 per inhaler.