The FDA has accepted Mylan’s abbreviated new drug application for its generic fluticasone propionate/salmeterol DPI and has set a GDUFA goal date of March 28, 2017, the company said. Mylan filed the ANDA for the generic version of GSK’s Advair Diskus in January 2016.
Mylan CEO Heather Bresch commented, “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 said, “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.”
Read the Mylan press release.
