Perrigo Co. PLC expects the U.S. Food and Drug Administration to reject its application to sell a generic version of Teva Pharmaceutical Industries Ltd.'s ProAir inhalation aerosol.
The inhaler, which utilizes albuterol sulfate, is approved for use in patients 4 years and older to treat or prevent certain disorders that affect the airways. Teva's ProAir is approved to treat or prevent bronchospasm with reversible obstructive airway disease and to prevent exercise-induced bronchospasm.
Perrigo, based in Ireland, expects the regulator to issue a complete response letter relating to its abbreviated new drug application for generic ProAir, after which it will evaluate the FDA's comments and address them.
The FDA issues a complete response letter to indicate that the review cycle for an application is complete and that the application is not ready for approval.
Because it expects the application to be rejected, Perrigo does not anticipate meeting its goal to launch a generic version of ProAir in the fourth quarter. Therefore it no longer expects to achieve a benefit of about 9 cents per share as stated in its 2018 reported and adjusted EPS guidance range.