US FDA approves Perrigo and Catalent's abbreviated new drug application for generic albuterol sulfate inhalation aerosol
25 February 2020 -

The United States Food and Drug Administration (FDA) has approved United States-based Perrigo Company plc's (NYSE; TASE:PRGO) and its partner, Catalent Pharma Solutions' abbreviated new drug application for generic albuterol sulfate inhalation aerosol, the first AB-rated generic version of ProAir HFA, it was reported on Monday.

Perrigo is introducing a limited quantity of generic albuterol sulfate inhalation aerosol and, in partnership with its development and manufacturing partner Catalent, is increasing production to meet future demand. ProAir HFA gross sales for the previous 12 months were approximately USD1.4 billion, according to the 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 specialised products to market that lower costs for consumers and payers.'