Perrigo anticipates it will be able to provide a steady supply of the inhaler by fourth quarter 2020. Courtesy Perrigo
A drug maker in the area received U.S. Food and Drug Administration (FDA) approval to produce and sell the first AB-rated generic version of the ProAir HFA albuterol inhaler.
Dublin, Ireland-based Perrigo — which has its North American headquarters in Allegan — said Tuesday the FDA approved its abbreviated new drug application for generic albuterol sulfate inhalation aerosol, the first AB-rated generic version of the ProAir HFA inhaler treatment.
ProAir HFA is a registered trademark of Teva Respiratory LLC. The brand’s gross sales in the past year were about $1.4 billion, as measured by global clinical research and consulting company IQVIA.
The Perrigo generic version will be “immediately” available in limited quantities to patients 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease — including asthma — and for the prevention of exercise-induced bronchospasm.
In collaboration with its development and manufacturing partner, Somerset, New Jersey-based Catalent, Perrigo is ramping up production to meet future demand.
Sharon Kochan, executive vice president and president, Rx Pharmaceuticals of Perrigo, said achieving FDA approval for this generic took about 10 years.
“We … anticipate that we will be in a position to provide a steady supply of this product by the fourth quarter of 2020,” she said.