Perrigo, Catalent get FDA nod for 1st generic metered-dose inhaler in 20 years

Perrigo and Catalent's recently approved complex generic is about to help patients breathe better. The Food and Drug Administration approved the companies' generic of Teva Respiratory's ProAir HFA (albuterol sulfate inhalation aerosol) — the first generic metered-dose inhaler to be approved in 20 years. 

The product is indicated for the treatment or prevention of bronchospasm in patients four years of age and older with reversible obstructive airway disease, and the prevention of exercise-induced bronchospasms. FDA commissioner Stephen Hahn noted that this is the first generic for one of the most commonly used rescue inhalers in the United States. 

"Metered-dose inhalers like these are known as complex generics, which are traditionally harder to copy because of their complex formulation or mode of delivery," Hahn said. "As a result, too many complex drugs lack generic competition even after patents and exclusivities no longer block generic approval."

Hahn said that supporting the development and approval of complex generics is a major focus of the agency in an effort to drive savings for patients.

"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 payers," said Sharon Kochan, Perrigo executive vice president and president of Rx pharmaceuticals. She noted that the company would be launching the generic immediately, with limited commercial quantities and the expectation that the company will be able to provide a steady supply by the fourth quarter of the year.

Jonathan Arnold, Catalent president, oral and specialty delivery said, "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 had a market value of approximately $1.4 billion for the previous 12 months, according to IQVIA.