News from the FDA/CDC

FDA approves generic Advair Diskus


The Food and Drug Administration has approved a generic version of the Advair Diskus, a complex device-drug combination containing fluticasone propionate and salmeterol inhalation powder.

The generic device will be available 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 FDA announcement. It will be marketed by Mylan as Wixela Inhub and will launch in late February, according to a statement from Mylan.

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Advair Diskus is among the most commonly used treatments for asthma and for chronic obstructive pulmonary disease (COPD), so it’s hoped this approval will increase access to the therapy, FDA officials said in a statement.

This approval is part of the FDA’s “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 a statement. “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.”

Wixela Inhub is indicated for twice-daily treatment of asthma in patients aged 4 years and older who are not adequately controlled by long-term asthma control treatments or whose disease warrants treatment with a combination of inhaled corticosteroids and long-acting beta agonists. It also is indicated for maintenance of COPD and reduction of COPD exacerbations.

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