Sandoz's Abbreviated New Drug Application for fluticasone propionate/salmeterol combination product, a substitutable generic version of Advair Diskus, was accepted by the U.S. Food and Drug Administration.
“Sandoz scientists and medical experts have developed a high-quality generic option that we believe offers asthma and COPD patients the same safety and efficacy that they expect from Advair Diskus,” Sandoz President Peter Goldschmidt said in a statement.
The drug, if approved by the FDA, will treat patients 4 and older who suffer from asthma. The product will also help with airflow obstruction and help reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD).
“We know the treatment of asthma and COPD place a significant cost burden on patients and the health care system in the U.S.,” 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.”
Sandoz is a global leader in generic pharmaceuticals and biosimilars and is a division of the Novartis Group.