Perrigo & Catalent Announce FDA Approval
Perrigo Company plc and its partner Catalent Pharma Solutions recently announced 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. 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.
Perrigo Executive Vice President and President, 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. 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 the FDA in over 20 years,” added 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.”
Perrigo Company plc is dedicated to making lives better by bringing Quality, Affordable Self-care Products that consumers trust everywhere they are sold. The company is a leading provider of over-the-counter health and wellness solutions that enhance individual well-being by empowering consumers to proactively prevent or treat conditions that can be self-managed. For more information, visit http://www.perrigo.com.
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 13,000 people, including approximately 2,400 scientists and technicians, at more than 35 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, NJ. For more information, visit www.catalent.com.
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