FDA Approves New Generic for Asthma, COPD

The FDA has approved the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for the twice-daily treatment of asthma in patients aged 4 years and older and for maintenance treatment of airflow obstruction and reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD).

The generic will be available in 3 strengths: fluticasone propionate 100 mcg/ salmeterol 50 mcg, fluticasone propionate 250 mcg/ salmeterol 50 mcg and fluticasone propionate 500 mcg/ salmeterol 50 mcg.

The most common adverse effects associated with the use of fluticasone propionate and salmeterol inhalation powder for the treatment of asthma include upper respiratory tract infection or inflammation, pharyngitis, dysphonia, oral candidiasis, bronchitis, cough, headaches, nausea, and vomiting. The most common adverse effects associated with their use for the treatment of COPD include pneumonia, oral candidiasis, throat irritation, dysphonia, viral respiratory infections, headaches, and musculoskeletal pain.

—Michael Potts

Reference:

FDA. FDA approves first generic Advair Diskus [press release]. January 30, 2019. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630151.htm.