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Fluticasone and Salmeterol & Brand to Generic Switching

    Basic Details
    Last Updated
    Thursday, March 28, 2024
    Original Posting Date
    Health Outcome(s)
    brand to generic switching
    Drug Use
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    Wixela Inhub (fluticasone propionate/salmeterol xinafoate) was the first approval for a generic inhaled product referencing Advair Diskus and was a significant milestone in establishing a bioequivalence pathway for future generic inhaled pulmonary products. FDA sought to describe the use of Advair Diskus and other brand inhaled corticosteroid (ICS) and long-acting beta-agonist (LABA) combination products in patients with chronic obstructive pulmonary disease (COPD) or asthma and switching patterns between Advair and other ICS/LABA products, including Wixela Inhub and the authorized generic (AG) for Advair Diskus.

    Results showed substantial use of multiple branded ICS/LABA combination products in Sentinel, with Advair Diskus and Symbicort being the most common in asthma and COPD patients. There were minimal differences in the characteristics across users of different ICS/LABA products. Only a small proportion of Advair Diskus users switched to another ICS/LABA product during the study period. Switching was more common in prevalent users than new users. Switch backs were rare, with the most common patterns being patients switching from Advair Diskus to Wixela Inhub or Advair AG and back to Advair Diskus. 

    Based on the available findings, FDA determined that no regulatory action was needed.