Public health agency The US Food and Drug Administration Wednesday authorised the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for the twice-daily treatment of asthma in patients with chronic obstructive pulmonary disease (COPD).
Advair Diskus (fluticasone propionate and salmeterol inhalation powder) has passed the US FDA's approval for the twice-daily treatment of asthma in patients aged four years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).
The agency's approval for the first generic Advair Diskus has been awarded to Mylan.
In addition, Mylan has received approval to market its generic inhaler in three strengths: fluticasone propionate 100 mcg/ salmeterol 50 mcg, fluticasone propionate 250 mcg/ salmeterol 50 mcg and fluticasone propionate 500 mcg/ salmeterol 50 mcg.
According to the National Heart, Lung, and Blood Institute, asthma is a chronic lung disease that inflames and narrows the airways. COPD is a progressive lung disease that can cause coughing that produces large amounts of mucus, wheezing, shortness of breath, chest tightness and other symptoms.
Additionally, the agency requires appropriate data and information to demonstrate that complex generic drug-device combination products meet the agency's rigorous approval standards to ensure quality drug products that are as safe and effective as their brand name counterparts are available to patients.
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