Perrigo and its partner, Catalent Pharma Solutions, announced the U.S. Food and Drug Administration (FDA) has approved Perrigo’s abbreviated new drug application for generic albuterol sulfate inhalation aerosol, the first AB-rated generic version of ProAir® HFA. Perrigo is launching a limited quantity of generic albuterol sulfate inhalation aerosol and, in collaboration with its development and manufacturing partner Catalent, is ramping up production to meet future demand.
Generic 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. ProAir® HFA gross sales for the previous 12 months were approximately $1.4 billion, as measured by IQVIA.
“Achieving FDA approval of this complex generic product was the outcome of an industry-leading collaboration in product development and regulatory expertise between Perrigo and Catalent that spanned over a decade,” Perrigo Executive Vice President and President, Rx Pharmaceuticals, Sharon Kochan said. “We are immediately launching with limited commercial quantities and anticipate that we will be in a position to provide a steady supply of this product by the fourth quarter of 2020. This approval and first-to-market generic launch is another vivid example of our team’s commitment and ability to bring new specialized products to market that lower costs for consumers and payors.”
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“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 twenty years,” said Jonathan Arnold, President, Oral and Specialty Delivery at Catalent. “The approval also highlights Catalent’s commercial manufacturing capability and complements the extensive product development and clinical-scale production capabilities at our North Carolina facility for Metered-Dose and Dry Powder Inhalers, and unit/bi-dose nasal drug-device combination products.”