(Bloomberg) -- Perrigo Co. said it expects U.S. regulators will reject its application for what one analyst had a called its must-have asthma inhaler, a generic version of Teva Pharmaceutical Industries Ltd.’s ProAir.
Perrigo said in a statement Friday that it was made aware that it would receive a Complete Response Letter from the U.S. Food and Drug Administration, delaying its plans to start selling the inhaler in the fourth quarter of this year.
The Dublin-based health-care company said the rejection will take about 9 cents out of its 2018 adjusted earnings target of $5.05 to $5.45 per share. Perrigo’s stock fell, losing 4.4 percent after the markets closed. Teva’s American depositary receipts were up less than 1 percent.
Perrigo has been tied up in a years-long battle with Teva over ProAir, an albuterol sulfate aerosol inhaler that treats asthma.
Perrigo’s prescription pharmaceutical business last year made up about 20 percent of its $4.95 billion in total revenue. Bringing the generic ProAir to market this year was a must- have to meet the company’s promise of more than $300 million in new drug products sales this year, Raymond James analyst Elliot Wilbur said in a note on Wednesday.
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