United Therapeutics Says Informed by Medtronics that FDA issued Response Letter Indicating PMA is Not Approvable; UTHR Expects FDA Action in 2016 Regarding NDA Seeking FDA Approval of New Labeling for Remodulin

On March 15, 2016, United Therapeutics Corporation UTHR was informed by Medtronic Inc. MDT that the U.S. Food and Drug Administration ("FDA") had issued a response letter to Medtronic's premarket approval application ("PMA") for the Remodulin Implantable System, indicating that the PMA is not approvable. In its response letter, the FDA noted various measures that Medtronic should take to make the PMA approvable. Medtronic and the Company are currently assessing the response letter and measures to address the agency's concerns. In parallel, the Company continues to expect FDA action in October 2016 regarding its new drug application ("NDA") seeking FDA approval of new labeling for Remodulin to allow administration with the Remodulin Implantable System. Both the NDA and PMA must be approved in order to launch the Remodulin Implantable System in the United States. For additional information regarding the Remodulin Implantable System development program, please refer to the Company's Annual Report on Form 10-K, filed with the Securities and Exchange Commission on February 25, 2016. The information contained in Item 7.01 to this Current Report on Form 8-K, and Exhibits 99.1 attached hereto, shall not be deemed to be "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to liability under that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.