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The U.S. FDA approved the first generic version of blockbuster drug Advair (fluticasone/salmeterol) for asthma maintenance treatment in patients aged 4 and up, and also for maintenance treatment and prevention of exacerbations in chronic obstructive pulmonary disease (COPD).
Mylan will make the generic alternative to fluticasone/salmeterol, which will be called Wixela Inhub and come in the same strengths as the original brand-name product. Advair's manufacturer GSK also authorized a generic equivalent of Advair to be made available immediately.
Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, announced in a press release:
Today's approval of the first generic drug product for one of the most commonly prescribed asthma and COPD inhalers in the US is part of our longstanding commitment to advance access to lower cost, high-quality generic alternatives."
Woodcock went on,
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."
Generic Advair was expected in 2018, but all three manufacturers vying to be first-to-market (Mylan, Sandoz and Hikman) experienced delays imposed by FDA, possibly due to challenges mass-producing a reliable substitute for Advair's blockbuster delivery device.
Mylan announced wholesale acquisition costs for Wixela Inhub of about $94 for the 100 mcg fluticasone product, to $153 for the 500 mcg product. According to Mylan, these prices are 70% less than Advair Diskus and 67% less than the GSK-authorized generic Advair. The company also emphasized that these wholesale prices may differ from those paid by patients or their payers.