The FDA announced the approval of the first generic version of Teva's ProAir HFA (albuterol sulfate) inhalation aerosol. FDA Commissioner Stephen Hahn noted that the approval "for one of the most commonly used rescue inhalers in the US 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."
ProAir HFA is indicated for the treatment or prevention of bronchospasm in patients four years of age and older with reversible obstructive airway disease and the prevention of exercise-induced bronchospasm, also in patients four years and older. Perrigo said it will launch a "limited quantity" of the AB-rated generic and, in collaboration with its partner Catalent, will boost production to meet future demand.
Sharon Kochan, executive vice president at Perrigo, indicated that the companies "will be in a position to provide a steady supply of this product by the fourth quarter of 2020." According to Perrigo, sales of ProAir HFA for the previous 12 months were approximately $1.4 billion.
"This is a significant technical achievement for both parties, as it is the first generic metered-dose inhaler to be approved by the FDA in over 20 years," commented Jonathan Arnold, president of oral and specialty delivery at Catalent. In 2018, Perrigo announced that the company had been informed the FDA would be issuing a complete response letter for its filing for generic ProAir HFA and that it would not meet its goal of launching the product in the fourth quarter of that year.
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