Mylan has submitted an abbreviated new drug application to the FDA for a generic equivalent to GlaxoSmithKline's Advair Diskus.
Mylan has submitted an abbreviated new drug application to the FDA for a generic equivalent to GlaxoSmithKline’s Advair Diskus.
If approved, Mylan would be able to manufacture and market fluticasone propionate 100, 250, and 500 mcg and salmeterol 50 mcg inhalation powder.
Advair Diskus is currently indicated for patients 4 years and older who have asthma or who need maintenance treatment of airflow obstruction.
Advair Diskus can also reduce exacerbations for patients with chronic obstructive pulmonary disease.
The most common adverse effects from using the Advair Diskus product include upper respiratory tract infection, throat irritation, and voice hoarseness. In some cases, it may also lead to fungal infections in the mouth or throat, pneumonia, a weakening of the immune system, or reduced adrenal function.