According to Mylan, the company will initiate a Phase 3 clinical trial of its generic version of Advair/Seretide Diskus for the treatment of asthma in October 2014, with an expected completion in April 2015. Mylan obtained global rights to the fluticasone/salmeterol inhaler from Pfizer in November 2011.
Mylan CEO Heather Bresch commented, “The commencement of Phase 3 clinical trials for Mylan’s generic Advair Diskus and insulin Glargine programs are important milestones in the progress of two of our strategic growth drivers, demonstrating our strong capabilities in developing complex, difficult-to-manufacture products. We look forward to providing patients with access to high quality, more affordable versions of these medications upon final FDA approval.”
Read the Mylan press release.