Mylan N.V. confirmed that it submitted its abbreviated new drug application (ANDA) for fluticasone propionate 100, 250, 500 mcg and salmeterol 50 mcg inhalation powder to the U.S. Food and Drug Administration in Dec. 2015. 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 will provide appropriate updates as the FDA process unfolds.