Originally a distributor of others’ products in southern West Virginia, Mylan grew over time into one of the world’s largest manufacturers of generic drugs. Mylan Announces FDA Approval of Wixela™ Inhub™ (fluticasone propionate and salmeterol inhalation powder, USP), First Generic of ADVAIR DISKUS® (fluticasone propionate and salmeterol inhalation powder)Wixela™ Inhub™ is the first FDA-approved therapeutically equivalent generic of ADVAIR DISKUS® (fluticasone propionate and salmeterol inhalation powder) for certain patients with asthma or chronic obstructive pulmonary disease (COPD)As a therapeutic equivalent, Wixela Inhub can be expected to have the same safety and efficacy profile as ADVAIR DISKUSFDA approval reinforces Mylan's commitment and relentless pursuit to increase access to complex treatment options for respiratory patientsFor further information: Christine Waller (Media), 724.514.1968; Melissa Trombetta (Investors), 724.514.1813 Experience the interactive Multichannel News Release here: Wixela Inhub will launch in the second half of February incorporating the latest safety information required by FDA earlier this month, which prompted an amendment to the label for certain inhaled corticosteroids, including ADVAIR DISKUS and any generic versions. Mylan B.V. Bezoekadres Krijgsman 20 1186 DM Amstelveen Postadres Postbus 167 1180 AD Amstelveen.

The Mylan logo is a registered trademark of Mylan Inc. Mylan President Rajiv Malik added, "We're pleased to offer the first FDA-approved generic of ADVAIR DISKUS, one of the leading treatments for asthma and COPD management today. Mylan undertakes no obligation to update these statements for revisions or changes after the date of this release. Mylan will provide appropriate updates as the FDA process unfolds. We have waited for years for generic inhalers to emerge in respiratory medicine," said Watch for Advair-Generic Potential Decision on March 28 Institutional investors will be intently focused on a potential FDA ruling on March 28th for the Advair generic. Share On the afternoon of June 13, 2018, we received an update from the U.S. Food & Drug Administration (“FDA”) concerning our pending approval for Generic Advair Diskus® that FDA has identified minor deficiencies to be relayed in a Complete Response Letter on June 27, 2018. Mylan (NSDQ:MYL) today announced the launch of its Wixela Inhub product, a generic for GlaxoSmithKline‘s (NYSE:GSK) Advair Diskus device, for people with asthma or chronic obstructive pulmonary disease.. We've long been confident in the science around this product and are proud of the dedication of our scientific teams to bring Wixela Inhub to market. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Asthma and respiratory specialists and primary care providers welcome this generic alternative to benefit many patients with asthma and COPD. The Mylan logo is a registered trademark of Mylan Inc. Close Mylan was founded in 1961 by two U.S. Army veterans wanting to help people in rural communities obtain quality, affordable medicines. Because our Abbreviated New Drug Application has received a priority designation, our approval could be received prior to the standard 90-day time period following the date of our response to the Complete Response Letter. Mylan NV on Tuesday priced its generic version of GlaxoSmithKline's blockbuster asthma treatment Advair 70 percent lower than the branded medicine. By clicking Continue below you are leaving Mylan.com and going to a third-party site. t +31 (0) 20-4263300 e office@mylan.nl. Customer Service (voor medische vragen kunt u contact opnemen met +31 (0) 20-4263300) Wixela Inhub will be available in the 100 mcg/50 mcg, 250 mcg/50 mcg and 500 mcg/50 mcg strengths for asthma patients and the 250 mcg/50 mcg strength for COPD patients.Wixela Inhub is indicated for the twice daily treatment of asthma in patients age 4 and older not adequately controlled on long-term asthma control medications or whose disease warrants initiation of treatment with both inhaled corticosteroids and long-acting beta agonists; maintenance treatment of COPD; and the reduction of COPD exacerbations in patients with a history of exacerbations.



Upon receipt of the official Complete Response Letter, we will determine what, if any, impact that it could have on our full year 2018 outlook. This information includes statements that constitute "forward-looking statements", including with regard to product approvals and outlook. The wholesale acquisition costs for Mylan’s Wixela Inhub devices are … The company touted that its device’s list price is 70% less than Advair Diskus and 67% less than GSK’s generic. It is not indicated for the relief of acute bronchospasm.The research and development program for Wixela Inhub compared all strengths of treatment to ADVAIR DISKUS in order to meet the FDA requirements of therapeutic equivalence for a substitutable generic.