Perrigo Expects Complete Response Letter On Generic Version Of ProAir®

DUBLIN, May 11, 2018 /PRNewswire/ -- Perrigo Company plc (NYSE; TASE: PRGO) today announced that it expects to receive a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its Abbreviated New Drug Application (ANDA) for its generic version of ProAir ®(albuterol sulfate) Inhalation Aerosol.

The 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 FDA informed the Company of this information via teleconference late in the afternoon on Thursday, May 10, 2018. Upon receipt of the Complete Response Letter, the Company will evaluate the FDA's comments and how to best address them.