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Perrigo will be producing a limited amount of the generic inhaler medication but will accelerate production to meet future demands in collaboration with Catalent.
Catalent and Perrigo Company, an Irish pharmaceutical manufacturer, announced on Feb. 24, 2020 that FDA approved Perrigo’s abbreviated new drug application for generic albuterol sulfate inhalation aerosol, the first generic version of ProAir HFA, an inhaler from Teva Respiratory used to treat bronchospasm.
According to a Catalent press release, generic albuterol sulfate inhalation aerosol is designated for patients four years of age and older for prevention and treatment of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm. Perrigo will be producing a limited amount of the generic but will accelerate production to meet future demands in collaboration with Catalent.
“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,” said Sharon Kochan, Perrigo executive vice-president and president, Rx Pharmaceuticals, in the press release. “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.”
“This is a significant technical achievement for both parties, as it is the first generic Metered-Dose Inhaler to be approved by [FDA] in over twenty years,” said Jonathan Arnold, president, Oral and Specialty Delivery at Catalent, in the press release. “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.”