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# FDA Rejects Sandoz Proposed Generic Advair
- URL: https://www.fdaweb.com/fda-rejects-sandoz-proposed-generic-advair/
- Published: 2018-02-08T12:00:00.000Z
- Updated: 2026-09-14T23:21:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140717

FDA has issued Sandoz a complete response letter, denying approval for its proposed generic copy of GlaxoSmithKline’s Advair Diskus (fluticasone propionate/salmeterol). The product is indicated for treating asthma in patients aged four years and older, in addition to providing maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease. The ANDA was accepted for review 6/2017\. At the time on submission, Sandoz noted that it acquired Oriel Therapeutics in 2010 that provided additional expertise in developing orally inhaled medicines.

  
The letter gives Glaxo additional time to market Advair without generic competition. It also demonstrates the difficulty companies are having in showing bioequivalence for proposed orally inhaled drug products. Last year, Mylan also was sent a complete response letter on its ANDA for a generic copy of Advair Diskus. In fact, Mylan CEO **Heather Bresch** told an 8/2017 financial outlook conference call that regulatory delays slowing its generic forms of the asthma drug and multiple sclerosis treatment Copaxone are tied to reorganization and new priorities at FDA. “We honestly see the administration as the barrier, and not the science,” Bresch declared. “We’re working diligently daily to be in constant contact with FDA and work through these issues.”