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Mylan Presents Equivalence and Device Usability Data on Wixela(TM) Inhub(TM) Compared to Advair Diskus® at American Thoracic Society International Conference | ||
By: PR Newswire Association LLC. - 18 May 2019 | Back to overview list |
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HERTFORDSHIRE, England, and PITTSBURGH, May 18, 2019 /PRNewswire/ -- Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced four scientific abstracts from the Wixela™ Inhub™ (fluticasone propionate and salmeterol inhalation powder, USP) development program that will be presented at the 2019 American Thoracic Society (ATS) International Conference in Dallas, May 17 – May 22. The data, available for the first time publicly, further supports the U.S. Food and Drug Administration's approval in January 2019 of Mylan's Abbreviated New Drug Application for Wixela Inhub, which is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD). Mylan President Rajiv Malik commented, "We are extremely proud to present for the first time publicly our rigorous data package that demonstrated therapeutic equivalence between Wixela Inhub and Advair Diskus®. The four studies being presented describe the pulmonary and systemic bioequivalence between the two products, device usability that enabled substitutability, and product and device robustness. The American Thoracic Society International Conference is the perfect forum to share with this important medical community the strong science that supported the introduction of the first FDA-approved therapeutically equivalent, substitutable generic of Advair Diskus®." Mylan's data will be presented during the following poster sessions at the meeting.
Full session details for the 2019 Scientific Sessions can be found at ATS website at conference.thoracic.org. About Wixela Inhub About Mylan View original content to download multimedia:http://www.prnewswire.com/news-releases/mylan-presents-equivalence-and-device-usability-data-on-wixela-inhub-compared-to-advair-diskus-at-american-thoracic-society-international-conference-300852813.html SOURCE Mylan N.V. |
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Copyright 2019 PR Newswire Association LLC. | Back to overview list |