Mylan N.V. (NASDAQ, TASE: MYL) today announced that its abbreviated new drug application (ANDA) for fluticasone propionate 100, 250, 500 mcg and salmeterol 50 mcg inhalation powder has been accepted for filing by the U.S. Food and Drug Administration (FDA). The FDA provided Mylan a GDUFA goal date of March 28, 2017. This product is the generic version of GlaxoSmithKline's Advair Diskus®, which is indicated for the treatment of asthma and the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).
Mylan CEO Heather Bresch said, "The FDA's acceptance of our ANDA filing is an important achievement for our generic Advair Diskus development program and our respiratory franchise as a whole. Leading up to this milestone, we held several discussions with FDA to provide input on and solidify our understanding of the agency's expectations for the development of the first AB-rated generic Advair Diskus product. Our ongoing dialogue with FDA and this ANDA filing acceptance gives us further confidence in the robustness of our clinical program and reinforces our continued belief that Mylan will be the first to bring to market an AB-rated, substitutable generic form of Advair Diskus."
Mylan President Rajiv Malik added, "The acceptance of our generic Advair Diskus ANDA filing demonstrates, yet again, Mylan's leadership in bringing high quality, affordable medicine to patients. I would like to thank our generic Advair team around the world, especially our teams in the U.K. and Ireland. We look forward to now working with FDA through the approval process to bring this very important product to patients."
Advair Diskus had U.S. sales of approximately $4.8 billion for the 12 months ending Dec. 31, 2015, according to IMS Health.
Currently, Mylan has 264 ANDAs pending FDA approval representing $102.3 billion in annual brand sales, according to IMS Health. Forty-eight of these pending ANDAs are potential first-to-file opportunities, representing $35.4 billion in annual brand sales, for the 12 months ending June 30, 2015, according to IMS Health.