11 May 2018 - Perrigo today announced that it expects to receive a complete response letter from the U.S. FDA regarding its abbreviated new drug application for its generic version of ProAir (salbutamol sulphate) inhalation aerosol. 

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. The FDA informed the Company of this information via teleconference late in the afternoon on Thursday, 10 May 2018. 

Upon receipt of the complete response letter, the Company will evaluate the FDA's comments and how to best address them.

Read Perrigo press release