Generics
Perrigo Company plc wins FDA approval for generic albuterol sulfate inhalation aerosol NDA for bronchospasm
25 February 2020 -

Health solutions company Perrigo Company plc (NYSE:PRGO) (TASE:PRGO) and its development and manufacturing partner Catalent jointly reported on Monday the receipt of approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application for generic albuterol sulfate inhalation aerosol for the treatment or prevention of bronchospasm.

The US Food and Drug Administration (FDA) has approved Perrigo's abbreviated new drug application for generic albuterol sulfate inhalation aerosol, the first AB-rated generic version of ProAir HFA.

Following the US FDA approval, Perrigo will now market a limited quantity of generic albuterol sulfate inhalation aerosol and, in partnership with its development and manufacturing partner Catalent, will increase the 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.

For the previous 12 months, ProAir HFA gross sales were approximately USD1.4bn, as measured by IQVIA.

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