The FDA has announced the approval of Perrigo’s ANDA for a generic of Teva’s ProAir HFA albuterol MDI for the treatment of asthma in patients 4 years old and older. Perrigo initially filed its ANDA for the generic version of ProAir HFA in 2012; Teva responded with a patent infringement suit. In 2014, the companies reached a settlement that would give Perrigo a license to market its version of ProAir in unlimited quantities beginning in July 2018; however, the FDA issued a complete response letter to Perrigo’s ANDA prior to that date.
FDA Commissioner Stephen M. Hahn commented, “Today’s approval of the first generic drug product for one of the most commonly used rescue inhalers in the US is part of our longstanding commitment to advance patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand name counterparts, and to expand opportunities to bring generic copies of complex drugs to the market. 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. As a result, too many complex drugs lack generic competition even after patents and exclusivities no longer block generic approval. Supporting development and approval of generic copies of these complex medicines so that these products can get to patients has been a major focus of our efforts to improve competition and access and to lower drug prices. Getting more generic copies of complex drugs to the market is a key priority for how we’ll help bring new savings to consumers.”
Perrigo Executive VP 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.”
Catalent President, Oral and Specialty Delivery, Jonathan Arnold added, “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.”
Read the FDA press release.
Read the Perrigo and Catalent press release.
