According to Novartis’s 2019 annual report, Novartis subsidiary Sandoz has discontinued development of a generic version of the Advair Diskus fluticasone propionate/salmeterol DPI for the treatment of asthma and COPD for the US market as of January 2020.
In October 2016, Sandoz filed a citizen petition with the FDA asking that the agency delay approval of 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. In March 2017, the FDA denied the citizen petition on technical grounds.
The FDA accepted Sandoz’s ANDA for the generic Advair inhaler in June 2017 and issued a complete response letter to that application in February 2018. In January 2019, the agency approved the first US generic version of Advair, Mylan’s Wixela Inhub. Hikma and Vectura continued to pursue approval of their generic Advair; in November 2019, Hikma submitted new data to the FDA in response to a 2017 CRL and a 2018 request for an additional clinical trial.
Read the Novartis annual report.
