FDA accepts Sandoz’s ANDA for generic version of Advair Diskus

According to Novartis, the FDA has accepted Sandoz’s abbreviated new drug application for its generic version of the Advair Discus (Seretide Accuhaler) fluticasone propionate/salmeterol DPI for the treatment of asthma and COPD. The company acquired the product when it acquired Oriel Therapeutics in 2010.

In October 2016, Sandoz filed a citizen petition with the FDA asking that the agency not approve any ANDAs for a generic version of Advair Diskus 100/50 until PK bioequivalence testing could be shown to account for batch-to-batch variability in the reference drug.

Elise Burmeister Getz of Oriel presented data on the batch-to-batch variability of the 100/50 version of Advair Diskus cited in the citizen petition at RDD 2017,.

In March 2017, the FDA denied the citizen petition on technical grounds. At about the same time, the agency issued a complete response letter to Mylan’s ANDA for a generic Advair and in May 2017, it issued a CRL for Hikma’s version.

Sandoz President Peter Goldschmidt said, “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. We know the treatment of asthma and COPD place a significant cost burden on patients and the healthcare system in the US. 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.”

Read the Novartis press release.