Research & Development
Perrigo announces US FDA's Complete Response Letter of generic ProAir
14 May 2018 -

Healthcare company Perrigo Company plc (NYSE:PRGO)(TASE:PRGO) said on Friday that it is awaiting a Complete Response Letter from the US Food and Drug Administration (FDA) regarding its Abbreviated New Drug Application (ANDA) for its generic version of ProAir (albuterol sulfate) Inhalation Aerosol.

According to the company, the ProAir (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.

Via teleconference on 10 May 2018, the US FDA issues a Complete Response Letter to indicate that the review cycle for an ANDA is complete and that the application is not ready for approval. The company will evaluate the US FDA's comments and how to best address them.

In conjunction with the US FDA's Complete Response Letter, the company does not expect to meet its goal of launching a generic version of ProAir in the fourth 2018. As a result, the Company no longer expects to achieve the approximately USD0.09 per share benefit that was included in its 2018 reported and adjusted earnings per share guidance range.

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