Mylan statement in response to FDA warning letter relating to certain Agila facilities

Mylan NV has commented on a warning letter issued by FDA on 6 August 2015, relating to its Agila Specialty Formulation Facility (SFF), Sterile Product Division (SPD), and Onco Therapies Limited (OTL) sites in India. This action follows inspections of the three sites by FDA as much as a year ago, in 2014 and February 2015, which Mylan has disclosed previously.

This Agency action has no material impact on Mylan's business or its previously announced full year earnings guidance.

Mylan CEO Heather Bresch commented: "Since Mylan acquired the Agila injectables businesses in December 2013 to create a leading global injectables platform, we have been taking extensive action to integrate the Agila business into Mylan's One Quality Standard, and to ensure our leading position as a high quality, reliable source of injectables for the long term. As part of this ongoing process, we have a deep and unwavering commitment to quality everywhere we operate. We have been and will continue to work diligently to address all of the FDA's observations and have made important progress."