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FDA approves first generic Advair Diskus for asthma, COPD
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The FDA recently issued approval to the first generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for reducing exacerbations and airflow obstruction in patients aged 4 years and older with asthma or COPD, according to a press release by the agency.
“Today’s approval of the first generic drug product for one of the most commonly prescribed asthma and COPD inhalers in the U.S. is part of our longstanding commitment to advance access to lower cost, high quality generic alternatives,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the release. “People living with asthma and COPD know too well the critical importance of having access to the treatment they need to feel better. Today’s approval will bring more competition to the market which will ultimately benefit the patients who rely on this drug.”
The generic, made by Mylan, was approved to be used via inhaler twice daily in three strengths:
- fluticasone propionate 100 µg/salmeterol 50 µg;
- fluticasone propionate 250 µg/salmeterol 50 µg; and
- fluticasone propionate 500 µg/salmeterol 50 µg.
For the treatment of asthma, the most common adverse events with fluticasone propionate and salmeterol inhalation powder included upper respiratory tract infection or inflammation, pharyngitis, dysphonia, oral candidiasis, bronchitis, cough, headaches, nausea and vomiting, according to the release.
For the treatment of COPD, the most common adverse events are pneumonia, oral candidiasis, throat irritation, dysphonia, viral respiratory infections, headaches and musculoskeletal pain, according to the release.