Irish OTC pharmaceuticals manufacturer Perrigo has secured the US Food and Drug Administration (FDA) approval for generic albuterol sulfate inhalation aerosol, the first generic version of ProAir HFA.

Perrigo said that it is launching the generic albuterol sulfate inhalation aerosol in a limited quantity and has collaborated with its development and manufacturing partner Catalent Pharma Solutions, to speed up the production.

Catalent oral and speciality delivery president Jonathan Arnold said: “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.

“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.”

ProAir HFA gross sales generated approximately $1.4bn in the last 12 months

Generic albuterol sulfate inhalation aerosol is indicated for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm in patients aged four years and older.

According to the biopharmaceutical firm IQVIA, gross sales of ProAir HFA in the previous 12 months generated approximately $1.4bn.

Perrigo claimed that its over-the-counter health and wellness solutions will enhance individual well-being by empowering consumers to actively prevent or treat self-managed conditions.

Perrigo executive vice president Sharon Kochan said: “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.

“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.”