The FDA announced that it has approved Mylan’s generic version of Advair Diskus fluticasone propionate/salmeterol DPI for the treatment of asthma in patients four years old and older and for the treatment of COPD. Three strengths were approved: FP 100 μg/salmeterol 50 μg, FP 250 μg/salmeterol 50 μg and FP 500 μg/salmeterol 50 μg.
In 2013, the FDA issued a draft product specific guidance for generic versions of Advair Diskus. Mylan’s ANDA for the DPI was accepted by the FDA in February 2016, with a PDUFA date of March 28, 2017. In March 2017, however, the company received a complete response letter in regards to the ANDA.
FDA Center for Drug Evaluation and Research Director Janet Woodcock commented, “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. 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.”
FDA Deputy Commissioner for Policy, Planning, Legislation and Analysis Anna Abram added, “The FDA recognizes challenges companies face when seeking to develop hard-to-copy complex generics, such as drug-device combination products, including when the drugs are incorporated into inhalation devices like this. We are committed to advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we’re prioritizing review of many applications covering proposed generic complex products for which a generic has not yet been approved.”
Read the FDA press release.
