The FDA accepted an abbreviated new drug application for Sandoz ANDA.
The US Food and Drug Administration (FDA) has accepted an abbreviated new drug application for Sandoz ANDA, a generic version of Advair Diskus.
The inhaler treatment — a fluticasone propionate and salmeterol combination product — would treat asthma in patients aged 4 years or older. It would also provide maintenance treatment of airflow obstruction and reduce exacerbations in chronic obstructive pulmonary disease (COPD) patients.
Advair Diskus, an inhaler glucocorticoid and long acting beta-2 agonist for asthma patients of a similar age, lost its US patent protection in 2010.
The generic treatment comes from Novartis division Sandoz, a manufacturer and developer in generic pharmaceuticals and biosimilars. Company president Peter Goldschmidt called Sandoz ANDA a high-quality generic option that they believe offers asthma and COPD patients “the same safety and efficacy that they expect from Advair Diskus.”
“We know the treatment of asthma and COPD place a significant cost burden on patients and the healthcare system in the US,” Goldschmidt said. “We are confident in our application and data, and we look forward to working with the FDA to provide greater access and affordability for this treatment option."