Approval has marked the first generic metered-dose inhaler to be approved by the FDA in over twenty years and will now be scaled-up
Perrigo Company and its partner, Catalent Pharma Solutions, have announced that the US FDA has approved Perrigo’s abbreviated new drug application for generic albuterol sulfate inhalation aerosol, the first AB-rated generic version of ProAir HFA (a registered trademark of Teva Respiratory).
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 four 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.
Perrigo Executive VP and President of Rx Pharmaceuticals, 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.”
Kochan explained that they are immediately launching with limited commercial quantities and anticipate that thye will be in a position to provide a steady supply of this product by the fourth quarter of 2020.
“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 of 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,” added Arnold.