FDA Announces First ProAir HFA Approval


The FDA announced the first approval of ProAir HFA—1 of the most popular inhalers in the US market.

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In a historic move, the US Food and Drug Administration (FDA) has announced the first approval of a generic of ProAir HFA (albuterol sulfate) Inhalation Aerosol.

The approval of Albuterol Sulfate Inhalation Aerosol, which was awarded to Perrigo Pharmaceutical Co., is for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease and the prevention of exercise-induced bronchospasm in patients four years of age and older.

“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,” said FDA Commissioner Stephen Hahn, MD, in the aforementioned statement.

According to prescribing information, ProAir HFA received approval for both of these indications in people 4 years of age and older in March 2012. The FDA’s statement noted the most common side effects associated with Albuterol Sulfate Inhalation Aerosol were headache, tachycardia, pain, dizziness, pharyngitis, rhinitis, chest pain, palpitations, tremor, and nervousness.

The FDA highlighted the role of the administration's Abbreviated New Drug Application (ANDA) program, which is designed to support the development of complex generic drug products, in the approval. Their statement also pointed out that draft product-specific guidance was released in 2016 for albuterol sulfate metered dose inhalers, including ProAir HFA.

“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 added. “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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