Mylan Files ANDA for Generic Version of GSK Respiratory Drug
Mylan N.V. has submitted its abbreviated new drug application for fluticasone propionate 100, 250, 500 mcg and salmeterol 50 mcg inhalation powder to the US Food and Drug Administration (FDA). The submission was made in December 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.
Mylan said it will provide appropriate updates as the FDA process unfolds.